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
Control
Standard care

Participants
Randomized
participants :
Hydroxychloroquine=169
Standard care=184
Characteristics of participants
N= 353
Mean age : NR
92 males
Severity : Mild: n= 293/ Asymptomatic: n=0
Number of vaccinated participants: NR
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 willing stated in the publication:
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 all available versions of the published article, the study registry was used in data extraction.
Quote: "This trial was a secondary study of the Barcelona Postexposure Prophylaxis Study against SARS-CoV-2 (BCN PEP CoV-2 Study) registered in ClinicalTrials.gov, NCT04304053"
No protocol or pre-specified statistical analysis plan are available. There was a change in the protocol for the intervention.
Quote: "Initially, the protocol included the use of HCQ and cobicistat-boosted darunavir (DRVc) combined treatment, but it was adapted to HCQ alone after the recommendation of the pharmaceutical company not to use DRVc for the treatment of Covid-19 due to lack of activity in-vitro and the negative results in human clinical trials of closely related HIV protease inhibitors."
Safety analysis was performed. Quote: "Twenty SAE were reported, 12 in the control arm and 8 in the intervention arm, none of them related to HCQ (Table S3)."