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

Pilot, randomized, multicenter, open-label clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of SARS-CoV-2 infection (COVID-19) - TCOVID

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001442-19-ES

Enrollment

276

Registered

2020-04-03

Start date

2020-04-02

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19

Interventions

Trade Name: RoActemra Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: TOCILIZUMAB CAS Number: 375823-41-9 Other descriptive name: TOCILIZUMAB Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate in-hospital mortality or mechanical ventilation in the Intensive Care Unit (ICU), or need for a rescue dose of tocilizumab in patients with confirmed infection by COVID-19 in treatment with hydroxychloroquine and azithromycin combined or non-tocilizumab.;Secondary Objective: To assess the clinical efficacy of tocilizumab in COVID-19 infection compared to the control arm by: Clinical severity: Patient score according to the WHO 7-point ordinal scale National Early Warning Score (NEWS) Oxygen therapy Mechanic ventilation Hospitalization Mortality at 15, 30 and 90 days To assess the safety of the intervention 30 days after treatment compared to the control arm. To assess the safety of the intervention at 90 days of treatment compared to the control arm. - Cumulative incidence of serious adverse effects (SAEs). - Cumulative incidence of grade 3 and 4 adverse effects (AEs). - Discontinuation or suspension of treatment for any reason. - Changes in the white blood cell count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, ferritin, fibrinogen, KL-6 during follow-up.;Primary end point(s): In-hospital mortality or need for mechanical ventilation in the Intensive Care Unit.;Timepoint(s) of evaluation of this end point: During hospitalization	—

Measure

Time frame

Main Objective: To evaluate in-hospital mortality or mechanical ventilation in the Intensive Care Unit (ICU), or need for a rescue dose of tocilizumab in patients with confirmed infection by COVID-19 in treatment with hydroxychloroquine and azithromycin combined or non-tocilizumab.;Secondary Objective: To assess the clinical efficacy of tocilizumab in COVID-19 infection compared to the control arm by: Clinical severity: Patient score according to the WHO 7-point ordinal scale National Early Warning Score (NEWS) Oxygen therapy Mechanic ventilation Hospitalization Mortality at 15, 30 and 90 days To assess the safety of the intervention 30 days after treatment compared to the control arm. To assess the safety of the intervention at 90 days of treatment compared to the control arm. - Cumulative incidence of serious adverse effects (SAEs). - Cumulative incidence of grade 3 and 4 adverse effects (AEs). - Discontinuation or suspension of treatment for any reason. - Changes in the white blood cell count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, ferritin, fibrinogen, KL-6 during follow-up.;Primary end point(s): In-hospital mortality or need for mechanical ventilation in the Intensive Care Unit.;Timepoint(s) of evaluation of this end point: During hospitalization

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Secondary

Measure	Time frame
Secondary end point(s): - Status of the ordinal scale evaluated on days 3, 5, 12, 15 and 30. - Evaluate the NEWS scale on days 3, 5, 12, 15 and 30. - Duration of oxygen therapy. - Duration of mechanical ventilation (if applicable). - Duration of hospitalization. - Date and cause of death (if applicable). - Grade 3 and 4 adverse effects. - SAEs. - Leukocyte count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, KL-6, ferritin, fibrinogen on days 1, 3, 5, 12 ( while hospitalization lasts) and 30 (if possible or if you are still admitted).;Timepoint(s) of evaluation of this end point: 3, 5, 12, 15 and 30 days	—

Measure

Time frame

Secondary end point(s): - Status of the ordinal scale evaluated on days 3, 5, 12, 15 and 30. - Evaluate the NEWS scale on days 3, 5, 12, 15 and 30. - Duration of oxygen therapy. - Duration of mechanical ventilation (if applicable). - Duration of hospitalization. - Date and cause of death (if applicable). - Grade 3 and 4 adverse effects. - SAEs. - Leukocyte count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, KL-6, ferritin, fibrinogen on days 1, 3, 5, 12 ( while hospitalization lasts) and 30 (if possible or if you are still admitted).;Timepoint(s) of evaluation of this end point: 3, 5, 12, 15 and 30 days

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Countries

Spain

Contacts

Public ContactUICEC Sant Pau

INSTITUT DE RECERCA H. SANTA CREU I SANT PAU

epenag@santpau.cat34935537636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026