COVID-19
Conditions
Brief summary
This study is a research project to evaluate the efficacy of hydroxychloroquine for post-exposure prophylaxis and early treatment of Covid-19. The intervention entails administering prophylactic hydroxychloroquine to all contacts (Study 1) and treating non severe confirmed cases with hydroxychloroquine (Study 2).
Detailed description
Hydroxychloroquine (HCQ) is a drug that has been extensively used for the prevention of malaria. HCQ showed excellent in vitro results and strong antiviral effects on SARS-CoV-2 infection of primate cells at low concentration. Empirical data for the efficacy of HCQ in hospitalized Covid-19 patients became available after the start of this study; HCQ administration did not result in a significantly higher PCR negative conversion in a RCT including 150 patients and there was no reduction in the risk of death/intubation in two large observational studies. Study 1 -We investigated the efficacy and safety of HCQ to prevent secondary SARS-CoV-2 infection and Covid-19 disease in contacts exposed to a PCR-positive Covid-19 case during. Study 2- We also conducted a study to test the hypothesis that HCQ treatment would be more efficacious than no-treatment for patients with mild Covid-19. Initially, the protocol included the use of combined treatment with a HIV protease inhibidor (cobicistat-boosted darunavir) for cases (study 2), 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.
Interventions
DRUGTreatment and prophylaxis
Cases will be offered a therapeutic regimen hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7 Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7.
OTHERStandard Public Health measures
Isolation of patient and contact tracing as per national guidelines.
Sponsors
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
Laboratorios Gebro Pharma SA
Laboratorios Rubió
Institut Catala de Salut
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open label
Intervention model description
Primary study: Cluster-randomized clinical trial of Covid-19 contacts Secondary study: Randomized clinical trial of Covid-19 cases
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Study 1: Inclusion Criteria for a contact: 1. Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact 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
for a contact: 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, haematopoietic 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. Study 2: Inclusion Criteria for a case: 1. Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute \<5 days respiratory infection symptoms, or fever alone, or acute cough alone and positive PCR) 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, including repeat nasal swab at day 3 6. Able to provide oral and written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study 1- Clinical and virological outcome in exposed contacts | Up to 14 days after start of treatment | Incidence of secondary PCR confirmed symptomatic Covid-19 episodes among contacts after high risk PCR+ exposure |
| Study 1- Transmission of SARS-CoV-2 in exposed contacts | Up to 14 days after start of treatment | Incidence of symptomatically compatible or a PCR-positive result regardless of symptoms |
| Study 2- Virological outcome in index cases | Up to 7 days after start of treatment | Reduction of viral RNA load in nasopharyngeal swabs at days 3, and 7 after treatment start. |
| Study 2- Clinical outcome in index cases | Up to 28 days after start of treatment | Time from randomization to complete resolution of symptoms at an extended 28-days follow- |
Countries
Spain
Outcome results
None listed