AMBUCOV: Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Recruiting

CT.gov ID

NCT04954040

Collaborator

(none)

132

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Covid19	Drug: Hydroxychloroquine Pill + Azithromycin Pill Drug: SOC	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19

Actual Study Start Date :

Feb 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Hydroxychloroquine Pill + Azithromycin Pill 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
Active Comparator: SOC (Standard of Care) SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed	Drug: SOC Acetaminophen or Metamizole. Antitussives if needed.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Hydroxychloroquine Pill + Azithromycin Pill

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

Active Comparator: SOC (Standard of Care)

SOC for symptoms treatment Acetaminophen or Metamizole, 1-1-1 Antitussives if needed

Drug: SOC

Acetaminophen or Metamizole. Antitussives if needed.

Outcome Measures

Primary Outcome Measures

Hospitalization [From randomization until patient's hospitalization happens, assessed up to 28 days.]
ICU admission [From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.]
Death [From randomization until death by any cause related to COVID19, assessed up to 28 days.]

Secondary Outcome Measures

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.]
Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.