Treatment of non-severe confirmed cases of COVID-19 and chemoprophylaxis of their contacts as prevention strategy: a Cluster Randomized Clinical Trial (PEP CoV-2 Study) - Treatment of COVID-19 Cases and Chemoprophylaxis of Contacts as Prevention

FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA0 sites3,040 target enrollmentApril 3, 2020

ConditionsSARS-CoV-2 Respiratory Viral Infection MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsRezolsta Dolquine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SARS-CoV-2 Respiratory Viral Infection
Sponsor: FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
Enrollment: 3040
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 3, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA

Eligibility Criteria

Inclusion Criteria

•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:

Exclusion Criteria

•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;