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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Unknown; Phase 2

Conditions: Acute Respiratory Distress Syndrome; Covid19

Treatments: Drug: SOC; Drug: Hydroxychloroquine Pill + Azithromycin Pill

Study type: Interventional

Funder types: Other

Identifiers

NCT04954040

AMBUCOV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Hydroxychloroquine + Azithromycin

Experimental group

Description:

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.

Treatment:

Drug: Hydroxychloroquine Pill + Azithromycin Pill

SOC (Standard of Care)

Active Comparator group

Description:

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

Treatment:

Drug: SOC