Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

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.

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.