Trial CTRI/2020/06/025575
Publication Panda PK(2), Clin Pharmacol, 2021 (published paper)
Dates: 2020-06-03 to 2020-10-30
Funding: No specific funding (Non-funded)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / India Follow-up duration (days): 28 | |
| Inclusion criteria | Consenting patients ≥18 years old; Diagnosed with symptomatic COVID-19 disease with a positive reverse-transcriptase–polymerase chain reaction (RT-PCR) assay for SARS-CoV-2 |
| Exclusion criteria | Patients on medications which were contraindicated with lopinavir/ritonavir, hydroxychloroquine/chloroquine, or ribavirin; Patients taking lopinavir ritonavir based anti-retroviral therapy or on hydroxychloroquine/chloroquine or ribavirin; Known allergic reactions to any of the drugs used in the treatment arms; Inability to take oral medications (lopinavir-ritonavir, hydroxychloroquine/ chloroquine, ribavirin); Pregnant or lactating females; Patients who had received any of the experimental therapies for 2019-nCoV (off-label, compassionate use, or trial-related) within 30 days before participation in the present study. |
| Interventions | |
| Treatment
Hydroxychloroquine+Ribavirin Initial dose: RBV 2400 mg orally as a loading dose. Maintenance dose: HCQ 400mg orally twice daily on day 1 followed by 400 mg orally once daily + RBV 1200 g orally every 12 hours, for 10 days |
|
| Control
Standard care ( / ) Definition of Standard care: Strict Isolation, Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask), Hydration, Proper Nutrition, Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant), Treatment of Comorbid Diseases, Oseltamivir (75 mg BD) for patients who are tested positive for H1N1. | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 43.3 26 males Severity : Mild: n=28 / Moderate: n=5/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1. Time to Clinical recovery (TTCR): TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. 2. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen. | |
| In the report Safety, clinical recovery of symptoms and laboratory recovery of each organ involvement, and time to SARS-CoV-2 RT-PCR negative report of nasopharyngeal/throat swab specimen. | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated
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| 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 study registry was used in data extraction and risk of bias assessment. The study did not achieve the target sample size specified in the trial registry. The dosage of medication was not reported in the study, therefore we are unable to determine if the were any changes from the trial registration in the intervention treatments. The primary outcome indicated in the registry reflects the primary outcome reported in the paper. Only serious adverse events were reported (i.e., non-serious adverse events are not reported). |