Trial NCT04304053
Publication Mitja O, Clin Infect Dis, 2020 (published paper)
Dates: 17mar2020 to 26may2020
Funding: Mixed (Crowdfunding campaign JoEmCorono; Laboratorios Rubio, Laboratorios Gebro Pharma, Zurich Seguros, SYNLAB Barcelona, Generalitat de Catalunya)
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Spain Follow-up duration (days): 28 | |
Inclusion criteria | Adult patients aged 18 years or more were eligible if they had mild symptoms of Covid-19 (i.e., fever, acute cough, shortness of breath, sudden olfactory or gustatory loss, or influenza-like-illness) for less than five days before enrollment, were non-hospitalized, and had a positive PCR test for SARS-CoV-2 in the baseline nasopharyngeal swab. |
Exclusion criteria | Patients were excluded if they had moderate-to-severe Covid-19 disease (e.g., required hospitalization), any condition that might preclude following the study procedures safely (e.g., mental disability), known allergy or hypersensitivity to study drugs, known retinal and severe liver or renal diseases, history of cardiac arrhythmia, known QT prolongation or other diseases that could be exacerbated by study drugs (e.g., psoriasis), active treatment with medications that are contraindicated with study drugs, or known HIV infection. Females who were pregnant (verbally declared or positive pregnancy test) or breastfeeding were also excluded. |
Interventions | |
Treatment
Hydroxychloroquine Initial dose: 800 mg orally on day 1; Maintenance dose: 400 mg once daily for 6 days |
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Control
Standard care Definition of Standard care: Usual care | |
Participants | |
Randomized 353 participants (n1=169 / n2= 184) | |
Characteristics of participants N=353 Mean age : 41.7 92 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register NR | |
In the report The reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start | |
Documents available |
Protocol NR 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 |
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General comment |