Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
Overview
- Phase
- Phase 2
- Intervention
- Hydroxychloroquine Pill + Azithromycin Pill
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Hospitalization
- Last Updated
- 4 years ago
Overview
Brief Summary
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
Detailed Description
In the patient group treated with hydroxychloroquine + azithromycin we expect to find a diminution of 20% or more regarding the evolution of acute respiratory syndrome, as opposed to patients who have not been treated with these medicines. To date, there is no shown effective treatment regime for acute respiratory distress caused by COVID-19.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with positive semi-quantitative PCR and COVID19 symptoms (fever, cough, diarrhea, dyspnoea, loss of smell).
- •Signed informed consent
Exclusion Criteria
- •Retinal degeneration.
- •Congenital or acquired long QT syndrome.
- •Advanced liver failure.
- •Renal insufficiency (incompatible with creatinine clearance less than 50 mL /minute).
- •Allergic to hydroxychloroquine or azithromycin.
- •Serious interaction with the drugs used.
- •Pregnant or breastfeeding.
- •Men and women in fertile and sexually active periods, who do not accept a highly effective contraceptive method.
- •Inability to follow study procedures.
Arms & Interventions
Hydroxychloroquine + Azithromycin
Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin. 1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0 Oral intake in all cases. Pills will be taken simultaneously.
Intervention: Hydroxychloroquine Pill + Azithromycin Pill
SOC (Standard of Care)
SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed
Intervention: SOC
Outcomes
Primary Outcomes
Hospitalization
Time Frame: From randomization until patient's hospitalization happens, assessed up to 28 days.
ICU admission
Time Frame: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
Death
Time Frame: From randomization until death by any cause related to COVID19, assessed up to 28 days.
Secondary Outcomes
- Clinical Evolution(From randomization until healing, hospitalization or death. Symptoms will be evaluated every 24 hours for a minimum of 10 days and a maximum 28 days.)