Trial NCT04318015
Publication Rojas-Serrano J
Dates: 4/21/2020 to 7/15/2020
Funding: Mixed (Instituto Nacional de Enfermedades Respiratorias (INER); CONACYT (national council of science and technology); SANOFI-AVENTIS)
Conflict of interest:
| Methods | |
| RCT | |
| Location :
Single center / Mexico Follow-up duration (days): 60 | |
| Inclusion criteria | Health care workers (nurses, nursing aides, cleaning staff, orderlies, respiratory therapists and physicians); 18 years old or older; with high-risk exposure to SARS-Cov-2 as they were taking care of hospitalized patients with COVID19; asymptomatic with a negative PCR-RT SARS-CoV2 test. |
| Exclusion criteria | Previous SARS-CoV2 infection; allergic to hydroxychloroquine; consumers of hydroxychloroquine or chloroquine (a 30 day wash out period was allowed); weight < 50 kg; pregnancy and nursing mothers; tamoxifen current users; history of chronic liver disease (Child-Pugh B or C); chronic renal disease with a glomerular filtration rate ? 30 ml/min. |
| Interventions | |
| Treatment
Hydroxychloroquine (*) Duration : 60 days |
|
| Control
Placebo Duration : 60 days | |
| Participants | |
| Randomized 130 participants (n1=65 / n2= 65) | |
| Characteristics of participants N=130 Mean age : NR 56 males | |
| Primary outcome | |
| In the register Symptomatic COVID-19 infection rate [ Time Frame: From date of randomization until the appearance of symptoms or study completion 60 days after treatment start ] | |
| In the report | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated 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 prospective trial registry was used in data extraction and assessment of risk of bias. There were no substantive differences between the registry and the pre-print article in procedures or interventions. Some secondary outcomes (e.g. adverse events and adherence to treatment) are reported in the paper, but not pre-specified in the trial registry. The registry included high-risk and low-risk cohorts whereas the pre-print article only reports recruitment of high-risk participants. Substantial proportions of both groups were lost to follow up in both arms (HCQ = 14/62 , placebo = 11/65) or discontinued the intervention, mostly due to adverse events (HCQ = 4/62, placebo = 5/65). The study was suspended due to slowed recruitment and losses to follow up after several trials reported lack of effectiveness of hydroxychloroquine. |