None listed
Conditions
Interventions
Standard of care Type of group
Standard of care that all patients with COVID recieve at the hospital.
Group name:Standard of care plus lopinavir with ritonavir plus interferon beta 1a Type of group
Standard care that is given to all COVID patients who come to this hospital / clinic plus Lopinavir with Ritonavir (orally twice a day for 14 days) plus interferon beta 1a (daily injection for 6 days). Lopinavir / Ritonavir is available from multiple manufacturers as fixed-dose thermostable tablets for oral administration: Lopinavir 200mg with Ritonavir 50mg per tablet. The oral solution for patients who cannot swallow is a light yellow to orange liquid containing 400 mg Lopinavir and 100 mg Rit
either 44 micrograms per 0.5 ml or 22 micrograms per 0.5 ml (allowing a convenient supply of 44 ug doses for subcutaneous use). The liquid should be clear to slightly yellow. Do not use if the liquid
Sponsors
OMS/OPS,
Eligibility
Inclusion criteria
Inclusion criteria: Adults ≥18 years, able to give informed consent, hospitalized or recently admitted as hospitalized patients diagnosed with COVID-19 and without advance transfer within 72 hours to a hospital that is not participating in the study. Patients invited to join the study will be those who report to hospitals / clinics, and there will be no other recruitment efforts
Exclusion criteria
Exclusion criteria: Research subjects under the age of 18, undiagnosed with COVID-19, with a history of known allergy and contraindications to study treatments (eg, chronic liver disease, chronic heart disease, or are pregnant).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Ratio of the number of deaths among patients enrolled in the study Measure:All-cause mortality Timepoints:5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Number of days of hospitalization among patients enrolled in the trial Measure:Evaluate the effects of the treatments on the duration of hospital stay Timepoints:5 months ; Outcome name:Proportion of patients who need ventilators and number of patients who are in the ICU Measure:Evaluate the effect of the treatments on the need for ventilators and the need to be in the intensive care unit Timepoints:5 months ; Outcome name:List the serious adverse reactions among patients in the study. Measure:Identify serious adverse reactions in patients who take antiviral treatments Timepoints:5 months | — |
Countries
Argentina, Bahrain, India, Iran, Norway, Peru, South Africa, Spain, Switzerland, Thailand
Contacts
Public ContactPatricia Garcia
MINISTERIO DE SALUD
Outcome results
None listed