Covid-19 living Data

Remdesivir vs Standard Care/Placebo (RCT)

Hospitalized patients

Abd-Elsalam S, Am J Trop Med Hyg, 2022 has been retracted on September 15, 2022. The study is excluded from the analysis and grade assessment.

FOREST PLOTS -2023-02-23

Studies description

Trial NCT04315948, EudraCT2020-000936-23
Publication DisCoVeRy - Ader F, Lancet Infect Dis (2022) (published paper)
Dates: 2020-03-22 to 2021-01-21
Funding: Public/non profit (European Union Commission, French Ministry of Health, DIM One Health Île-de France, REACTing, Fonds Erasme-COVID-ULB, Belgian Health Care Knowledge Centre (KCE))
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Austria, Belgium, France, Luxembourg, Portugal Follow-up duration (days): 90
Inclusion criteria	Hospitalised participants ≥18 years of age laboratory-confirmed SARS-CoV-2 infection illness of any duration at least one of the following: clinical assessment (evidence of rales/crackles on exam) and SpO2 ≤ 94% on room air, or requirement of supplemental oxygen, high flow oxygen devices, non-invasive ventilation and/or mechanical ventilation women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study written informed consent
Exclusion criteria	Liver enzymes (ALT/AST) > 5 times the upper limit of normal stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30 mL/min) anticipated transfer to another hospital which is not a study site within 72 hours contraindication to any study medication including allergy treated with one of the evaluated antivirals in the in the past 29 days or used ribavirin in the 29 days and/or concomitantly to randomisation pregnant or breast-feeding women
Interventions
	Treatment Remdesivir Initial dose: 200 mg IV on the first day -Maintenance dose: 100 mg IV once a day for 5-9 days
	Control Standard care
Participants
	Randomized participants : Standard care=428 Remdesivir=429
	Characteristics of participants N= 857 Mean age : NR 588 males Severity : Mild: n=15 / Moderate: n=482 / Severe: n=192 Critical: n=154
Primary outcome
	In the register Percentage of subjects reporting each severity rating on a 7-point ordinal scale [ Time Frame: Day 15 ]
	In the report Clinical status at day 15 as measured on the 7-point ordinal scale of the WHO
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print/published article, the published protocol, supplementary appendices, prospective online trial registries and data gained from contact with authors were used in data analysis and risk of bias assessment. The pre-print reported on an interim analysis for the remdesivir intervention arm of a multiple-arm platform study (DisCoVeRy, an add-on trial to the WHO Solidarity consortium) that was terminated early due to futility. Consequently, the planned sample size was not achieved and long-term outcomes were not reported. Other than that, there were no substantial changes to procedures, population, or interventions. The outcome WHO Score 7 or above includes participants with events within 28 days rather than at 28 days. Mortality at day 28 was reported but not extracted due to overlapping patient population with Pan, N Engl J Med, 2020. On 12th of July, 2021, this study was updated based on updated pre-print. On 6th of October, 2021, this study was updated based on the published article. On 16th of November, 2021, this study was updated based on data from contact with authors. On 14th of April, 2022, this study was updated based on the preprint reporting on the final results. On the 18th of November, 2022, this study was updated with the final results extracted from the publication.

Trial NCT04330690
Publication Ali K, CMAJ (2022) (published paper)
Dates: 2020-08-14 to 2021-04-01
Funding: Public/non profit (Canadian Institutes of Health Research, the Vancouver Coastal Health Research Institute, the Northern Alberta Clinical Trials and Research Centre, Covenant Health Research Centre, the McGill Interdisciplinary Initiative in Infection and Immunity, the St. Joseph’s Health Care Foundation, and the London Health Sciences Foundation)
Conflict of interest: Yes

Trial NCT04321616
Publication NOR-SOLIDARITY - Barratt-Due A, Ann Intern Med (2021) (published paper)
Dates: 2020-04-07 to 2020-10-04
Funding: Mixed (National Clinical Therapy Research in the Specialist Health Services, Norway; Gilead Sciences (drug donation))
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Norway Follow-up duration (days): 90
Inclusion criteria	Adults (≥18 years) laboratory-confirmed SARS-CoV-2 infection admitted to the hospital ward or the intensive care unit with no anticipated transfer to a non-study hospital within 72 hours of inclusion.
Exclusion criteria	Severe co-morbidity with life expectancy <3 months AST/ALT > 5 times the upper limit of normal QTc-time >470 ms pregnancy breast-feeding acute co-morbidity occurrence in a 7-day period before inclusion known intolerance to study drugs participation in a potentially confounding trial or concomitant medications interfering with the study drugs.
Interventions
	Treatment Remdesivir Initial dose: 200 mg/day IV- Maintenance dose: 100 mg/day for up to 9 days
	Control Standard care
Participants
	Randomized participants : Remdesivir=43 Standard care=58
	Characteristics of participants N= 101 Mean age : NR 72 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Primary outcome
	In the register All cause in-hospital mortality [Time Frame: 3 weeks]
	In the report In-hospital mortality (i.e. death during the original hospitalization; follow-up ceased at discharge), regardless of whether death occurred before or after day 28
Documents avalaible	Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Low
General comment	In addition to the peer-reviewed journal and pre-print articles, the study registry and protocol were used in data extraction and risk of bias assessment. NOR-Solidarity includes additional data collected beyond the WHO Solidarity core follow-up. Whereas the remdesivir arm was continued in the WHO Solidarity trial, it was stopped in the NOR-Solidarity study, on October 5th due to 1) general low mortality in hospitalized patients in Norway, 2) the potential for untoward effects in ventilated patients, and 3) potentially little, if any, effect of remdesivir for patients with mild disease. Some outcomes were reported at a different follow-up point than pre-specified in the registry. In-hospital mortality is reported. On 27th of July, 2021, this study was updated based on the published article.

Trial NCT04280705
Publication Beigel JH, N Engl J Med (2020) (published paper)
Dates: 21feb2020 to 2020-04-20
Funding: Mixed (National Institute of Allergy and Infectious Diseases and others)
Conflict of interest: No

Methods
	RCT Blinding:
	Location : Multicenter / USA, Denmark, UK, Greece, Germany, Korea, Mexico, Spain, Japan, Singapore Follow-up duration (days): 28
Inclusion criteria	Participants had to meet one of the following criteria suggestive of lower respiratory tract infection at the time of enrollment: radiographic infiltrates by imaging study, peripheral oxygen saturation (SpO2) ≥ 94% on room air, or requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). There was no limit to the duration of symptoms prior to enrollment. Participants had to have a laboratory-confirmed SARS-CoV-2 infection as determined by a positive reverse transcription, polymerase-chain-reaction (RT-PCR) assay result from any respiratory specimen collected <72 hours prior to randomization. During the study, this criterion was modified due to limitations in testing capacity to also allow a RT-PCR positive specimen that was collected ≥72 hours prior to randomization if the site was unable to obtain a repeat sample and if the participant had progressive disease consistent with ongoing SARS-CoV-2 infection. Other inclusion criteria included agreeing not to participate in another COVID-19 treatment clinical trial through Day 29 and practicing heterosexual abstinence or using study-specified contraception through Day 29 for women of childbearing potential.
Exclusion criteria	Alanine aminotransferase (ALT) or an aspartate aminotransferase (AST) > 5 times the upper limit of the normal range impaired renal function as determined by calculating an estimated glomerular filtration rate (eGFR), or need for hemodialysis or hemofiltration allergy to study product pregnancy or breast-feeding and anticipated discharge from the hospital or transfer to another hospital within 72 hours of enrollment
Interventions
	Treatment Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily for up to 9 additional days
	Control Placebo
Participants
	Randomized participants : Remdesivir=541 Placebo=521
	Characteristics of participants N= 1062 Mean age : NR 684 males Severity : Mild: n=138 / Moderate: n=435 / Severe: n=193 Critical: n=285
Primary outcome
	In the register Time to recovery [ Time Frame: Day 1 through Day 29 ]
	In the report Time to recovery, defined as the first day, during the 28 days after enrollment, on which a patient satisfied categories 1, 2, or 3 on the eight-category ordinal scale
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of the published/pre-print article, the study registry, protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The final report was published in the New England Journal of Medicine on October 8, 2020 and the data (for 29 day follow-up). Data were also posted on the registry website, clinicaltrials.gov on September 25th, 2020 which contained data through day 29 of follow-up. The original report, published on May 22, 2020, presented preliminary results up to day 14. After interim data analysis, the data and safety monitoring board recommended that the preliminary primary analysis report and mortality data be provided to trial team members from the National Institute of Allergy and Infectious Diseases (NIAID). These results were made public and were accessible to the treating physicians, who could request to be made aware of the treatment assignment of trial participants who had not completed day 29 if clinically indicated. Participants assigned to the placebo group could be given remdesivir. The study had a larger sample size than the target sample size specified in the trial registry (n=800). There was no change from the trial registration in the intervention and control treatments. The primary outcome measurement changed from the first version to the protocol, and is described in the second version of the protocol (both are provided in the article appendix). The authors provide an explanation for this decision, which took place before interim analysis, and was proposed by statisticians who had no knowledge of outcome data. This trial was updated on February 9th, 2021 after contact with authors.

Trial NCT05041907
Publication PLATCOV - Jittamala P, medRxiv (2022) (preprint)
Dates: 2021-09-30 to 2022-06-10
Funding: Public/non profit (Wellcome Trust)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Thailand, Brazil Follow-up duration (days): 28
Inclusion criteria	Previously healthy adults aged between 18 and 50 years early symptomatic COVID-19 (i.e. reported symptoms for <4 days), oxygen saturation ≥96% unimpeded in activities of daily living fully informed consent SARS-CoV-2 positivity defined either as a nasal lateral flow antigen test which became positive within two minutes (STANDARD™ Q COVID-19 Ag Test, SD Biosensor, Suwon-si, Korea) or a positive PCR test within the previous 24hrs with a cycle threshold value (Ct) <25 (all viral gene targets), both suggesting high viral loads
Exclusion criteria	Taking any potential antivirals or pre-existing concomitant medications chronic illness or significant comorbidity hematological or biochemical abnormalities pregnancy (a urinary pregnancy test was performed in females) breastfeeding contraindication or known hypersensitivity to any of the study drugs
Interventions
	Treatment Remdesivir Initial dose: 200 mg IV infusion on day 1 - Maintenance dose: 100 mg IV infusion daily days 2-5
	Control Standard care
Participants
	Randomized participants : Standard care=69 Remdesivir=67
	Characteristics of participants N= 136 Mean age : NR 59 males Severity : Mild: n=136 / Moderate: n=0 / Severe: n=0 Critical: n=0
Primary outcome
	In the register Rate of viral clearance for newly available and repurposed drugs [ Time Frame: Days 0-7 ] ; Rate of viral clearance for positive controls (e.g. monoclonal antibodies) [ Time Frame: Days 0-7 ] ; Rate of viral clearance for small novel molecule drugs [ Time Frame: Days 0-7 ]
	In the report Viral clearance rate derived from the slope of the log10 oropharyngeal viral clearance curve over the first 7 days following randomization. The treatment effect is defined as the multiplicative change in viral clearance rate relative to the no study drug arm.
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. A target sample size was not pre-specified in this adaptive platform trial. There is no change from the trial registration in the intervention and control treatments. The registry primary outcome reflects the reported primary outcome. Total adverse events are not reported.

Trial *
Publication Mahajan L, Indian J Anaesth (2021) (published paper)
Dates: 2020-06-01 to 2020-12-30
Funding: No specific funding (None)
Conflict of interest: No

Trial ISRCTN83971151; NCT04315948
Publication SOLIDARITY (RDV) - Pan H, N Engl J Med (2020) (published paper)
Dates: 2020-03-22 to 2020-10-04
Funding: Mixed (World Health Organization; Gilead Sciences (drug donation))
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Multinational (30) Follow-up duration (days): 28
Inclusion criteria	Age ≥18 years, hospitalized with a diagnosis of COVID-19, not known to have received any study drug, without anticipated transfer elsewhere within 72 hours, and, in the physician’s view, with no contra-indication to any study drug.
Exclusion criteria	The only exclusions were patients without clear consent to follow-up
Interventions
	Treatment Remdesivir 200 mg IV infusion at day-0 followed by 100 mg once a day for next 9 days
	Control Standard care
Participants
	Randomized participants : Remdesivir=2750 Standard care=2725
	Characteristics of participants N= 5475 Mean age : NR 3431 males Severity : Mild: n=1325 / Moderate: n=* / Severe: n=* Critical: n=*
Primary outcome
	In the register All-cause mortality, subdivided by the severity of disease at the time of randomization, measured using patient records throughout the study
	In the report In-hospital mortality
Documents avalaible	Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Low
General comment	In addition to all available versions of the published manuscript, the pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment. This was a report of interim results of an adaptive trial evaluating 4 drugs: Remdesivir, Hydroxychloroquine, Lopinavir, and Interferon-β1a. No target sample size was pre-specified. Quote: "The protocol stated “The larger the number entered the more accurate the results will be, but numbers entered will depend on how the epidemic develops… it may be possible to enter several thousand hospitalised patients with relatively mild disease and a few thousand with severe disease, but realistic, appropriate sample sizes could not be estimated at the start of the trial.” The Executive Group, blind to any findings, decided the timing of release of interim results." Quote: "The hydroxychloroquine, lopinavir, and interferon regimens were discontinued for futility on, respectively, June 19, July 4, and October 16, 2020." There was no change from the trial registration in the intervention and control treatments, nor in the primary and secondary outcomes. This study was updated on December 9th using data from the published manuscript.

Trial NCT04292730
Publication Spinner CD, JAMA (2020) (published paper)
Dates: 2020-03-15 to 2020-04-18
Funding: Private (Gilead Sciences)
Conflict of interest: Yes

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Multinational Follow-up duration (days): 28
Inclusion criteria	Patients must meet all of the following inclusion criteria to be eligible for participation in this study: 1. Willing and able to provide written informed consent (participants >= 18 years of age) or assent (participants >= 12 and < 18 years of age) prior to performing study procedures. For participants >= 12 and < 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures 2. Aged >=18 years (at all sites), or aged >= 12 and < 18 years of age weighing <= 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board [IRB] or independent ethics committee [IEC]) 3. SARS-CoV-2 infection confirmed by PCR? 4 days before randomization 4. Currently hospitalized and requiring medical care for COVID-19 5. SpO2 > 94% on room air at screening 6. Radiographic evidence of pulmonary infiltrates 7. Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
Exclusion criteria	Patients who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Participation in any other clinical trial of an experimental agent treatment for COVID-19 2. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing Remdesivir (RDV GS-5734TM) 3. Requiring mechanical ventilation at screening 4. ALTorAST>5xULN 5. Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants ??? 18 years of age and Schwartz Formula for participants < 18 years of age 6. Positive pregnancy test 7. Breastfeeding woman 8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient
Interventions
	Treatment Remdesivir 200 mg IV infusion on day-1 followed by 100 mg once a day for next 9 days Remdesivir 10 days 200 mg IV infusion on day-1 followed by 100 mg once a day for next 9 days Remdesivir 5 days 200 mg IV infusion on day-1 followed by 100 mg once a day for next 4 days
	Control Standard care
Participants
	Randomized participants : Remdesivir=396 Remdesivir 10 days=197 Remdesivir 5 days=199 Standard care=200
	Characteristics of participants N= 992 Mean age : NR 475 males Severity : Mild: n=660 / Moderate: n=111 / Severe: n=6 Critical: n=0
Primary outcome
	In the register The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 11 [ Time Frame: Day 11 ] The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical stat
	In the report Clinical status assessed by a 7-point ordinal scale on Day 11
Documents avalaible	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the study registry, protocol, SAP and supplementary files were used in data extraction and risk of bias assessment. This is a report on a multinational 3 arm RCT in Phase A and Phase B is ongoing. Quote: "In addition, a non-randomized extension phase was added in which up to 1000 additional patients could be enrolled to receive remdesivir; the results of the extension phase will be the subject of a subsequent report". The target sample size specified in the registry 1113 was not yet achieved. There is no change from the trial registration in the intervention and control treatments. Secondary outcomes in the report are not specified in the trial registry however they are congruent with the protocol. Quote: "The protocol was amended on March 15, 2020, on the basis of emerging understanding of the clinical presentation and assessment of COVID-19. The age limit for eligibility was lowered from 18 years to 12 years and the minimum temperature requirement was eliminated. The primary end point in the original protocol was the proportion of patients discharged by day 14 of the study. This was amended to assessment of clinical status on a 7-point ordinal scale by day 11

Trial NCT04257656
Publication Wang Y, Lancet (2020) (published paper)
Dates: 06feb2020 to 12mar2020
Funding: Mixed (Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project)
Conflict of interest: Yes

Methods
	RCT Blinding: Participants, outcome assessor and health care pro
	Location : Multicenter / China Follow-up duration (days): 28
Inclusion criteria	Men and non-pregnant women with COVID-19 who were aged at least 18 years and were RT-PCR positive for SARS-CoV-2, had pneumonia confirmed by chest imaging, had oxygen saturation of 94% or lower on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and were within 12 days of symptom onset. Eligible patients of child-bearing age (men and women) agreed to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration.
Exclusion criteria	Pregnancy or breast feeding hepatic cirrhosis alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m²) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis possibility of transfer to a non-study hospital within 72 h and enrolment into an investigational treatment study for COVID-19 in the 30 days before screening. The use of other treatments, including lopinavir–ritonavir, was permitted.
Interventions
	Treatment Remdesivir 200 mg IV infusion at day-1 followed by 100 mg IV infusion once a day for next 9 days
	Control Placebo
Participants
	Randomized participants : Remdesivir=158 Placebo=79
	Characteristics of participants N= 237 Mean age : NR 140 males Severity : Mild: n=0 / Moderate: n=0 / Severe: n=235 Critical: n=1
Primary outcome
	In the register Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ]
	In the report Time to clinical improvement within 28 days after randomisation
Documents avalaible	Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the study registry and protocol were used in data extraction and risk of bias assessment. There was no a-priori statistical analysis plan. The study is underpowered, because recruitment was terminated early by the data safety and monitoring board, on the basis of the termination criteria specified in the protocol. With the actual number of participants (vs the target sample size), the statistical power was reduced from 80% to 58%. There is no change from the trial registration in the intervention and control treatments. The outcome adverse events is reported in the paper, but was not pre-specified in the trial registry/protocol. On July 15th 2020, we received additional information from authors on this study.

Methods
	RCT Blinding: Unblinded
	Location : Multicenter / Canada Follow-up duration (days): 60
Inclusion criteria	Adults laboratory-confirmed SARS-CoV-2 infection admitted to participating hospitals
Exclusion criteria	Allergy to study drug anticipated transfer to a nonstudy site expected to not survive beyond 24 hours or already receiving remdesivir at time of enrolment
Interventions
	Treatment Remdesivir Initial dose: 200 mg intravenously on day 0 - Maintenance dose: 100 mg intravenously on days 1 through 9.
	Control Standard care
Participants
	Randomized participants : Remdesivir=634 Standard care=648
	Characteristics of participants N= 1282 Mean age : NR 766 males Severity : Mild: n=125 / Moderate: n=697 / Severe: n=347 Critical: n=112
Primary outcome
	In the register All-cause mortality [Time Frame: 29 days]
	In the report In-hospital mortality
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	High
General comment	“In addition to the published article, the supplemental appendix and study registry were used in data extraction and risk of bias assessment. Neither the protocol nor the statistical analysis plan was available. There is no change from the trial registration in the remdesivir and control treatments. The registry primary outcome is different from the reported primary outcome (all-cause mortality vs in-hospital mortality [Time Frame: 29 days].The estimated sample size (n=2900 participants) specified in the trial registry corresponds to a 3-arms in a 1:1:1 ratio randomization to either the control arm, consisting of standard supportive care treatment for COVID-19, or remdesivir plus standard supportive care or Interferon-beta-1a plus standard supportive care."

Methods
	RCT Blinding: Unblinded
	Location : Single center / India Follow-up duration (days): 24
Inclusion criteria	Hospitalised patients aged between 18 and 60 years age SARS‑CoV‑2 infection confirmed by polymerase‑chain‑reaction assay within the last 4 days respiratory rate >24/min radiographic evidence of pneumonia oxygen saturation of 94% or less creatinine clearance above 40 ml per minute.
Exclusion criteria	Patients on mechanical ventilation or with multiorgan failure serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of the normal range creatinine clearance below 40 ml per minute.
Interventions
	Treatment Remdesivir Initial dose: 200 mg IV 3 to 4 times a day for the first 24 hours -Maintenance dose: 100 mg IV once daily for 4 days.
	Control Standard care
Participants
	Randomized participants : Remdesivir=41 Standard care=41
	Characteristics of participants N= 82 Mean age : NR 48 males Severity : Mild: n=0 / Moderate: n=53 / Severe: n=17 Critical: n=0
Primary outcome
	In the register NR
	In the report Improvement in clinical outcomes
Documents avalaible	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Not reported
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	High
General comment	Only the published article was used in data extraction and assessment of the risk of bias. No trial registry, protocol or statistical analysis plan was available. The study sample size was reached. Outcome data assessed as per-protocol analysis. The study was assessed to be at a high risk of bias due to some concerns in four of five domains.