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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-18

Study Completion Date

2020-06-15

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary study: Cluster-randomized clinical trial of Covid-19 contacts

Secondary study: Randomized clinical trial of Covid-19 cases

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Open label

Study Groups

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No Intervention- SARS-CoV-2 surveillance

Study 1- Contacts will complete a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and day 14.

Study 2- Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3 and 7.

Isolation of patient and contact tracing as per national guidelines.

Group Type ACTIVE_COMPARATOR

Standard Public Health measures

Intervention Type OTHER

Isolation of patient and contact tracing as per national guidelines.

Testing, treatment and prophylaxis of SARS-CoV-2

Study 1- Contacts receive Hydroxychloroquine prophylaxis. Contacts will complete a survey collecting demographic, epidemiological and clinical and provides a swab for RT-PCR testing at baseline and day 14.

Study 2- Index case receives Hydroxychloroquine. Index case completes a survey collecting demographic, epidemiological and clinical data and provides a swab for RT-PCR testing at baseline and on days 3, and 7.

Isolation of patient and contact tracing as per national guidelines.

Group Type EXPERIMENTAL

Treatment and prophylaxis

Intervention Type DRUG

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.

Standard Public Health measures

Intervention Type OTHER

Isolation of patient and contact tracing as per national guidelines.

Interventions

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Treatment 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.

Intervention Type DRUG

Standard Public Health measures

Isolation of patient and contact tracing as per national guidelines.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

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

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, 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:

1. Hospital admission
2. 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;
3. 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;
4. Participants under treatment with medications likely to interfere with experimental drugs
5. Unable to take drugs by mouth;
6. With significantly abnormal liver function (Child Pugh C)
7. Need of dialysis treatment, or GFR≤30 mL/min/1.73 m2;
8. Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
9. Participants with severe neurological and mental illness;
10. Pregnant or lactating women;
11. Inability to consent and/or comply with study protocol;
12. Individuals with known hypersensitivity to the study drugs.
13. Persons already treated with any of the study drugs during the last 30 days.
14. Any contraindications as per the Data Sheet of Hydroxychloroquine.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes