COVID
Conditions
Brief summary
As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is Azithromycin, used to treat a wide variety of bacterial infections, Ivermectin, an anti-parasitic drug and the other is Cholecalciferol to increase serum concentration of 25-hydroxyvitamin D.
Detailed description
The aim of the study is to assess the efficacy of Ivermectin-Azithromycin-Cholecalciferol combination in COVID-19 in early stages of the disease with outpatient management. Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 30 cases of COVID-19 will be enrolled into the trial with a 3:1 proportion, divided into two groups. First group with confirmed cases of COVID-19 shall be treated with Ivermectin (6mg once daily in day 0,1,7 and 8) plus Azithromycin (500mg once daily for 4 days) plus Cholecalciferol (400 IU twice daily for 30 days) in an outpatient regimen. The second group with confirmed cases of COVID-19 who refused treatment were shall be allocated as the control group for monitoring. Test for virus at day 1 and 14 from beginning of trial drug started for the outpatient regimen. Clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the trial.
Interventions
DRUGIvermectin
6mg once daily in day 0,1,7 and 8
DRUGAzithromycin
500mg once daily for 4 days
DRUGCholecalciferol
400 IU twice daily for 30 days
Sponsors
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Relation 3:1 in Combination:Control groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed infection of SARS-CoV2 virus * Mild COVID-19 * Symptoms of respiratory illness * Cough * Fever (T \>38 °C)
Exclusion criteria
* Allergy to any of the drugs treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral clearance | 14 days | Test for virus at day 1 and 14 from beginning of trial drug started |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms duration | 14 days | The duration of symptoms in days |
| SpO2 | 14 days | oxygen saturation |
| SpO2/FiO2 | 14 days | Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio |
Countries
Mexico
Outcome results
None listed