Hydroxychloroquine sulfate early administration in symptomatic out of hospital COVID-19 positive patients. Hydro-Stop-COVID19 Trial

Phase 1

• Conditions: Emerging disease (COVID-19) due to a novel coronavirus (named SARS-CoV-2 latter) started in Wuhan, China and rapidly spread in China and outside and has been declared pandemic by WHO on March 12th 2020. It has been shown that an excessive immune response to the SARS-CoV-2 virus would results in hyper-inflammation, with excessive increase of cytokines IL6 and IL10. This may progress to a cytokine storm, followed by multiorgan failure and potentially death.; MedDRA version: 21.1Level: LLTClassification code 10063099Term: Viral syndromeSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001558-23-IT
• Lead Sponsor: ASUR (Azienda Sanitaria Unica Regionale) Marche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-26
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

1.Patients with SARS-CoV-2 infection in a nasopharyngeal sample, with diagnosis, carried out in a centralized core-lab.
2.Patients confined at home because their clinical picture was judged by the local Health authorities not severe enough to require hospitalization.
3.Patients agree to maintain seclusion at home up to viral negativization of the nasopharyngeal test in two consecutive samples, according to Italian laws.
4.Patients with 1 or more of the following symptoms/signs on the day of nasopharyngeal sample: 1) Fever (>37.0° Celsius); 2) Cough.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Age <18 years.
2.Allergy to HCQ or chloroquine.
3.Contraindication to treatment with the study drug for one or more of the following conditions: retinopathy, G6PD deficiency, Long-QT syndrome or treatment with drugs associated with QTc prolongation (unless these drugs can be safely discontinued during HCQ treatment). Appendix 1 shows a table, derived from AIFA, which lists these drugs.
4.Breastfeeding and pregnant patients will be excluded based on their declaration and pregnancy test results when required.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of out-of-hospital treatment with HCQ in the reducing viral loads and need for hospitalization in symptomatic SARS-CoV-2 infected patient who are confined at home.;Secondary Objective: NA;Primary end point(s): virological clearance (nasopharyngeal sample negative for SARS-CoV-2 virus) at the sample taken on days 8. Co-primary end-point: Hospital admission over the time-interval between day 0 (randomization) and day 15.;Timepoint(s) of evaluation of this end point: 7-15 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Need for intubation during the interval between day 0 (randomization) and day 15; <br>b) All-cause death during the interval between day 0 (randomization) and day 15. <br>c) Virological clearance in all samples (both day 8 and day 15)<br>d) Composite of a), b), c). The first-occurring component will be considered for analysis.;Timepoint(s) of evaluation of this end point: 15-28 days