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

Covid19 Clinical Trial

— AMBUCOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954040
• Other study ID #: AMBUCOV
• Status: Recruiting
• Phase: Phase 2
• Start date: February 10, 2021
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: Antonio Miguel Luque Pineda
• Phone: +34 671 596 070
• Email: uicec[@]imibic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Covid19
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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
• SOC
Acetaminophen or Metamizole. Antitussives if needed.

Locations

Country	Name	City	State
Spain	Centro de Salud Priego de Córdoba	Priego de Córdoba	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization		From randomization until patient's hospitalization happens, assessed up to 28 days.
Primary	ICU admission		From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days.
Primary	Death		From randomization until death by any cause related to COVID19, assessed up to 28 days.
Secondary	Clinical Evolution	Clinical evolution will be evaluated through the following symptoms: fever, cough, dyspnoea, diarrhea, loss of smell.	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.