SOLIDARITY: AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL TO EVALUATE NON-LICENSED COVID-19 TREATMENTS IN ADDITION TO STANDARD OF CARE AMONG HOSPITALIZED PATIENTS

• Register: RPEC
• Last refreshed on: 18 December 2023
• Main ID: PER-010-20
• Date of registration: 16/04/2020
• Prospective Registration: No
• Primary sponsor: OMS/OPS,
• Public title: SOLIDARITY: AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL TO EVALUATE NON-LICENSED COVID-19 TREATMENTS IN ADDITION TO STANDARD OF CARE AMONG HOSPITALIZED PATIENTS
• Scientific title: SOLIDARITY: AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL TO EVALUATE NON-LICENSED COVID-19 TREATMENTS IN ADDITION TO STANDARD OF CARE AMONG HOSPITALIZED PATIENTS
• Date of first enrolment: 03/04/2020
• Target sample size: 1000
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=010-20
• Study type: Interventional
• Study design: The novel coronavirus that causes the disease COVID-19 is an international crisis that at the point of this request has caused more than 700,000 cases and 33,000 deaths worldwide. There are currently no vaccines or authorized treatments for COVID-19. Although treatments for other diseases may be of some help, they may not be. Therefore, the World Health Organization is organizing a study in many countries in which some of these treatments are compared to see if they are useful for the treatment of COVID-19. A randomized controlled trial with the following 5 treatments is proposed. 1.Standard care that is given to all COVID patients who come to participating hospitals. OR Standard care that is given to all COVID patients who come to participating hospitals plus one of the following: 2.Remdesivir (daily infusion for 10 days) 3. Hydroxychloroquine (two oral doses, then orally twice daily for 10 days) 4.Lopinavir with Ritonavir (orally twice daily for 14
• Phase: III

Countries of recruitment

Argentina, Bahrain, India, Iran, Norway, Peru, South Africa, Spain, Switzerland, Thailand

Contacts

• Name: Patricia Funegra Garcia
• Affiliation: MINISTERIO DE SALUD

• Name: Patricia Funegra Garcia
• Affiliation: MINISTERIO DE SALUD

Key inclusion & exclusion 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: 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).

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

-B342 Coronavirus infection, unspecified site
Coronavirus infection, unspecified site

B342

Intervention(s)

Group name:Standard of care Type of group;2 N° of participants:200 Intervention(s) description: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;1 N° of participants:200 Intervention(s) description: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 Ritonavir per 5 ml (80 mg Lopinavir and 20 mg Ritonavir per ml). Interferon beta 1a is supplied as a sterile solution that does not contain any preservative available in a pre-filled syringe. It is provided as a single dose pre-filled graduated syringe available in two strengths; 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 is cloudy, discolored or contains particles. Use a different syringe. Contains the following inactive ingredients: Albumin (Human), Mannitol, Sodium Acetate, Water for Injection.

Primary Outcome(s)

Outcome name:Ratio of the number of deaths among patients enrolled in the study
Measure:All-cause mortality
Timepoints:5 months

Secondary Outcome(s)

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:List the serious adverse reactions among patients in the study.
Measure:Identify serious adverse reactions in patients who take antiviral treatments
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

Source(s) of Monetary Support

Organizacion Mundial de la Salud

Ethics review

Status: Approved
Approval date:
Contact:

Comite Nacional Transitorio de Etica en Investigacion para la Evaluacion y Supervision de Etica de los Ensayos Clinicos de la Enfermedad COVID-19

Status: Approved
Approval date: 16/04/2020
Contact:

Comite Nacional Transitorio de Etica en Investigacion para la Evaluacion y Supervision de Etica de los Ensayos Clinicos de la Enfermedad COVID-19

Status: Approved
Approval date: 08/05/2020
Contact:

Comite Nacional Transitorio de Etica en Investigacion para la Evaluacion y Supervision de Etica de los Ensayos Clinicos de la Enfermedad COVID-19

Results

• Results available: Yes
• Date Completed: 28/01/2021