Trial NCT04323527
Publication Borba MGS, JAMA Netw Open, 2020 (published paper)
Funding: Public/non profit (Government of the Amazonas State, Farmanguinhos (Fiocruz), Superintendencia da Zona Franca de Manaus, Coordination for the Improvement of Higher Education Personnel, Fundacao de Amparo a Pesquisa do Estado do Amazonas, and federal funds)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Single center / Brazil Follow-up duration (days): 28 | |
| Inclusion criteria | Hospitalized patients with clinical suspicion of COVID-19 (ie, history of fever and any respiratory symptom, eg, cough or rhinorrhea), aged 18 years or older at the time of inclusion, with respiratory rate higher than 24 rpm and/or heart rate higher than 125 bpm (in the absence of fever) and/or peripheral oxygen saturation lower than 90% in ambient air and/or shock (ie, arterial pressure lower than 65mmHg, with the need for vasopressor medicines, oliguria, or a lower level of consciousness) were included. Patients younger than 18 yearswere not included due to the known lower morbidity and mortality from COVID-19 in this group. |
| Exclusion criteria | Children and adolescents will be excluded. |
| Interventions | |
| Treatment
Chloroquine 450mg 450 mg orally or via nasogastric tube twice a day on day 0, then 450 mg once a day for the next 4 days |
|
| Control
Chloroquine 600mg (600mg) Duration : 10 days | |
| Participants | |
| Randomized 81 participants (n1=40 / n2= 41) | |
| Characteristics of participants N=81 Mean age : 51.1 61 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register Absolute mortality at day 28 (compared between groups) | |
| In the report Mortality by day 28 | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated No |
| 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/pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment. The study was terminated early due to the between-group difference in mortality. As a result, the target sample size specified in the registry was not achieved, some efficacy outcomes were not reported in the paper, and some outcomes were reported at an earlier follow-up point than pre-specified in the registry. There is no change from the trial registration in the intervention and control treatments. |