Clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of COVID-19

Phase 1

• Conditions: COVID19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001442-19-ES
• Lead Sponsor: INSTITUT DE RECERCA H. SANTA CREU I SANT PA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-03
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

1. Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
2. Understand and agree to abide by the study procedures.
3. Adult =18 years of age at the time of inclusion in the study.
4. Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
5. Gravity 3-4 according to the WHO 7-point ordinal scale:
- Severity 3. Hospitalized, which does not require supplemental oxygen
- Severity 4. Hospitalized, requiring supplemental oxygen
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 276
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. ALT / AST> 5 times the normal limit
2. Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
3. Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
4. Advanced dementia.
5. Pregnancy or breastfeeding.
6. Forecast of transfer to another center in the 12 hours at the beginning of the study.
7. Allergy to study medication.
8. Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
9. Streptococcus pneumoniae antigenuria positive before study start.
10. Neutropenia <500 / mm3.
11. Plateletpenia <100,000 / mm3.
12. History of diverticulosis.
13. Ongoing skin infection (eg, pyodermitis).
14. Transplanted patient under immunosuppressive treatment.
15. Previous evidence of latent untreated tuberculosis.

Study & Design

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