Covid-19 living Data

Baloxavir marboxil vs Standard care (RCT)

Hospitalized patients

FOREST PLOTS -2021-05-20

Studies description

Trial ChiCTR2000029544
Publication Lou Y, Eur J Pharm Sci (2020) (published paper)

Funding: Public/non profit (Zhejiang Provincial Science and technology department key R & D plan emergency project)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / China Follow-up duration (days): 14
Inclusion criteria	(1) Adults 18-85 years of age, either man or woman, who have signed the informed consent voluntarily (2) Confirmed as COVID-19: positive results of throat swab or blood samples by real-time RT-PCR assay for 2019-nCoV (3) No difficulty in swallowing oral drugs (4) Ability to follow the protocol according to the judgment of researchers.
Exclusion criteria	(1) Allergic constitution, known to be allergic to baloxavir marboxil or favipiravir or pharmaceutical excipients (2) Weight < 40 kg (3) Critical illness meeting one of the following conditions: respiratory failure and mechanical ventilation shock other organ failure requiring ICU monitoring and treatment (4) Renal insufficiency (estimated creatinine clearance < 60 ml/min) (5) With any of the following laboratory parameter abnormalities detected within 24 hours before screening(according to local laboratory reference range): ALT or AST level > 5 times the upper limit of normal range (ULN) , or ALT or AST level > 3-fold ULN and total bilirubin level > 2-fold ULN (6) Base on the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study midway, such as other serious diseases, serious laboratory examination abnormalities, other factors that affect the safety of the subject or study data and blood sample collection.
Interventions
	Treatment Favipiravir Initial dose: 1600 or 2200 mg orally, followed by 600 mg three times a day for maximum 14 days Baloxavir marboxil 80 mg orally on day 1 and day 4, a third dose could be given on day 7
	Control Standard care
Participants
	Randomized participants : Favipiravir=10 Baloxavir marboxil=10 Standard care=10
	Characteristics of participants N= 30 Mean age : NR 21 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0
Primary outcome
	In the register Time to viral negativity by RT-PCR; Time to clinical improvement.
	In the report Percentage of subjects with viral negative by Day 14; Time from randomization to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live
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	Some concerns
General comment	In addition to all available versions of the published article, the study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. On September 21st 2020, we received additional information from authors on this study.