Trial NCT04304053
Publication Mitja O, N Engl J Med, 2020
Dates: 3/17/2020 to 4/28/2020
Funding: Mixed (Crowdfunding campaign YoMeCorono; Laboratorios Rubió, Laboratorios Gebro Pharma; Zurich Seguros; SYNLAB Barcelona; Generalitat de Catalunya)
Conflict of interest: No conflicts of interest
| Methods | |
| RCT | |
| Location :
Multicenter / Spain Follow-up duration (days): 28 | |
| Inclusion criteria | 1. Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a
healthcare worker, a household contact, a nursing home worker or nursing home resident.
2. Aged ≥18 years male or female. 3. In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study. 4. Willing to take study medication. 5. Willing to comply with all study procedures. 6. Able to provide oral, informed consent and/or assent. |
| Exclusion criteria | 1. With known history of cardiac arrhythmia (or QT prolongation syndrome).
2. Unable to take drugs by mouth. 3. With significantly abnormal liver function (Child Pugh C) 4. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2. 5. Participants with psoriasis, myasthenia, hematopoietic and retinal diseases, CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit. 6. Persons already treated with any of the study drugs during the last 30 days. 7. Pregnant or lactating women. 8. Any contraindications as per the Data Sheet of Hydroxychloroquine. |
| Interventions | |
| Treatment
Hydroxychloroquine (*) Duration : 7 days |
|
| Control
Standard care Definition of Standard care: * Duration : NA | |
| Participants | |
| Randomized 2525 participants (n1=1225 / n2= 1300) | |
| Characteristics of participants N=2525 Mean age : 48.7 626 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
| Primary outcome | |
| In the register 1. Clinical and virological outcome in exposed contacts [Time Frame: Up to 14 days after start of treatment] Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure; and 2. Transmission of SARS-CoV-2 in exposed contacts [Time Frame: Up to 14 days after start of treatment] Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms | |
| In the report Onset of a confirmed Covid-19 episode, defined as symptomatic illness (at least one of the following symptoms: fever, cough, difficulty breathing, myalgia, headache, sore throat, new olfactory and taste disorder(s), or diarrhea) and a positive SARS-CoV-2 RT-PCR test | |
| Documents avalaible |
Protocol Yes. In English 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 report, the registry was used to extract data. This study uses the number of randomized participants as |