Trial CTRI/2020/04/024729
Publication Thakar A, Indian J Med Res, 2021 (published paper)
Dates: 2020-04-23 to 2020-05-06
Funding: Public/non profit (All India Institute of Medical Sciences, New Delhi)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / India Follow-up duration (days): 10 | |
| Inclusion criteria | Patients referred for admission with a COVID-19 RT-PCR test reported positive from a panel of government-approved laboratories; asymptomatic or mildly symptomatic adults [National Early Warning Score (NEWS) ≤4] |
| Exclusion criteria | Recent intake of oral chloroquine or hydroxychloroquine or any other specific treatment; hypersensitivity to chloroquine or hydroxychloroquine; cardiovascular comorbidities; pregnant or lactating ladies |
| Interventions | |
| Treatment
Chloroquine ( / )Co-Intervention: Standard care Duration : |
|
| Control
Standard care ( / ) Definition of Standard care: standard symptomatic supportive care | |
| Participants | |
| Randomized 60 participants (n1=30 / n2= 30) | |
| Characteristics of participants N=60 Mean age : 34.9 47 males Severity : Mild: n=60 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1) The Ct values on Day 0, 3, 7, 10 shall be plotted on a graph for all patients; 2) The rate of decline for each patient shall be calculated. The time to cure (Covid 19 RT PCR -ve.) shall be determined. 3) The two groups shall be compared for a. Rate of decline of Ct values, b. Time to Cure, c. Rate of Cure or alternate outcome | |
| In the report Drug tolerance, clinical and virological metrics. Toxicity assessment was carried out by direct verbal questioning and subsequent investigations as required. General well-being was assessed daily along with the evaluation of the breath-holding time and documentation of the NEWS on days 0, 3, 7 and 10. Nasal swabs were taken on days 0, 3, 7 and 10 and tested by real-time RT-PCR targeting the ORF1ab gene (BGI Genomics Co. Ltd., China) on Agilent AriaMx real-time PCR system. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 prospective study registry was used in data extraction and risk of bias assessment. Authors indicate that no target sample size was defined. There is no change from the trial registration in the intervention and control treatments. Time to viral negative conversion was pre-specified in the registry but no results were reported for this outcome in the published paper. Some outcomes (e.g., adverse events, serious adverse events) are reported in the paper, but were not pre-specified in the trial registry. Some outcomes (e.g., general well-being, breath holding time) were specified in the methods section of the published article but no results were reported. |