Status:
COMPLETED
Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Germans Trias i Pujol Hospital
Department of Health, Generalitat de Catalunya
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hydro...
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 c...
Eligibility Criteria
Inclusion
- Study 1:
- Inclusion Criteria for a contact:
- Asymptomatic individuals exposed to a PCR confirmed COVID19 case within 7 days as either a healthcare worker or household contact
- Aged ≥18 years male or female;
- In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
- Willing to take study medication;
- Willing to comply with all study procedures;
- Able to provide oral, informed consent and/or assent.
- Exclusion Criteria for a contact:
- With known history of cardiac arrhythmia (or QT prolongation syndrome);
- Unable to take drugs by mouth;
- With significantly abnormal liver function (Child Pugh C)
- Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
- Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit;
- Persons already treated with any of the study drugs during the last 30 days;
- Pregnant or lactating women;
- Any contraindications as per the Data Sheet of Hydroxychloroquine.
- Study 2:
- Inclusion Criteria for a case:
- 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)
- Aged ≥18 years male or female;
- In women of childbearing potential, negative pregnancy test and commitment to use contraceptive method throughout the study.
- Willing to take study medication
- Willing to comply with all study procedures, including repeat nasal swab at day 3
- Able to provide oral and written informed consent
- Exclusion Criteria for a case:
- Hospital admission
- Serious condition meeting one of the following: (1) respiratory distress with respiratory rate \>=30 breaths/min; (2) oxygen saturation\<=93% on quiet status; (3) Arterial partial pressure of oxygen (PaO2)/oxygen concentration\<=300mmHg;
- Critically ill patients meeting one of the following: (1) Experience respiratory failure and need to receive mechanical ventilation; (2) Experience shock; (3) Complicated with other organs failure and need intensive care and therapy in ICU;
- Participants under treatment with medications likely to interfere with experimental drugs
- Unable to take drugs by mouth;
- With significantly abnormal liver function (Child Pugh C)
- Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
- Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
- Participants with severe neurological and mental illness;
- Pregnant or lactating women;
- Inability to consent and/or comply with study protocol;
- Individuals with known hypersensitivity to the study drugs.
- Persons already treated with any of the study drugs during the last 30 days.
- Any contraindications as per the Data Sheet of Hydroxychloroquine.
Exclusion
Key Trial Info
Start Date :
March 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
2300 Patients enrolled
Trial Details
Trial ID
NCT04304053
Start Date
March 18 2020
End Date
June 15 2020
Last Update
June 30 2020
Active Locations (1)
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1
Departament de Salut
Barcelona, Spain