Treatment of non-severe confirmed cases of coronavirus and treatment of their contacts as preventio
- Conditions
- SARS-CoV-2 Respiratory Viral InfectionMedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - InvestigationsMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001031-27-ES
- Lead Sponsor
- FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 3040
Inclusion Criteria for Index Cases:
1.Patients who meet the requirements of the New Coronavirus Infection Diagnosis (Acute respiratory infection symptoms or acute cough alone and positive PCR)
2.Aged =18 years male or female
3.In women of childbearing potential(1), negative pregnancy test and commitment to use contraceptive method(2) 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
2Contraceptive methods: male or female condom with or without spermicide, cap, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study.
Data currently available in population older than 65 years are limited, so caution will be taken before administering Rezolsta to patients of this age. This will be minimized as a thorough review of the clinical records including laboratory tests in advance.
Inclusion Criteria for contacts:
1.Patients who meet the definition of a contact according to the Catalan Public Health Department Guidelines
2.Aged =18 years male or female;
3.Willing to take study medication;
4.Willing to comply with all study procedures;
5.Able to provide oral, informed consent and/or assent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2432
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 608
Exclusion Criteria for Index Cases:
1.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;
2.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;
3.Participants under treatment with medications likely to interfere with experimental drugs Unable to take drugs by mouth;
4.With significantly abnormal liver function (Child Pugh C)
5.Need of dialysis treatment, or GFR=30 mL/min/1.73 m2;
6.Participants with psoriasis, myasthenia, haematopoietic and retinal diseases,CNS-related hearing loss or glucose-6-phosphate dehydrogenase deficit
7.Participants with severe neurological and mental illness;
8.Pregnant or lactating women;
9.Inability to consent and/or comply with study protocol;
10.Individuals with known hypersensitivity to the study drugs;
11.Persons already treated with any of the study drugs during the last 30 days.
12.Concomitant administration of enzyme inducers (such as carbamazepine) which could lead to ineffectiveness of darunavir; and those who receive CYP3A4 substrates (such as statins) because of the risk of increased toxicity.
13.HIV patients (because these are already on antiretroviral treatment)
14.Any contraindications as per the Data Sheet of Rezolsta or Hydroxychloroquine.
Exclusion Criteria for contacts:
1. Participants under treatment with medications likely to interfere with experimental drugs
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 Participants with retinal disease, hearing loss;
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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: -Evaluate the transmissibility of SARS-CoV-2 and reduction of disease progression within the study population over the course of the outbreak.<br>-Explore the effect of the intervention on patient individual parameters.<br>;Secondary Objective: -Feasibility of implementation of treatment strategy<br>-Cost effectiveness of test-and-treat intervention<br><br>;Primary end point(s): Outcome Measures [Population level]:<br>1.Ring prophylaxis effectiveness to reduce development of disease assessed by Incidence of secondary cases (basic case reproduction number) among contacts of a case <br>2.Ring prophylaxis effectiveness to reduce transmissibility assessed by PCR conversion to positive of contacts that are negative at baseline <br><br>Outcome Measures [COVID-19 case Individual outcomes]:<br>1.Symptom type, duration and severity among SARS-CoV-2 positive cases [<br>;Timepoint(s) of evaluation of this end point: Up to 14 days after start of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Outcome Measures [Population level]:<br>3.Feasibility of implementation of treatment strategy <br>4.Cost effectiveness of test-and-treat intervention <br><br>Outcome Measures [COVID-19 case Individual outcomes]:<br>2.The virological clearance rate of throat swabs, sputum, or lower respiratory tract secretions at days 3 <br>3.The mortality rate of subjects at weeks 2 <br>4.Proportion of participants that drop out of study <br>5.Proportion of participants that show non-compliance with study drug <br>6.Proportion of participants that show non-compliance with public health measures <br>7.Drug levels and biomarkers of severity of infection <br>;Timepoint(s) of evaluation of this end point: Up to 6 months