Acute Respiratory Distress Syndrome, Covid19
Conditions
Keywords
acute respiratory syndrome, SARS-CoV-2, COVID19, hydroxychloroquine, azithromycin, COVID19 symptoms
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.
Interventions
DRUGHydroxychloroquine 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
DRUGSOC
Acetaminophen or Metamizole. Antitussives if needed.
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death | From randomization until death by any cause related to COVID19, assessed up to 28 days. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
Primary ContactAntonio Miguel Luque Pineda
Outcome results
None listed