Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger

Covid-19 Clinical Trial

— TRASCOV  

Official title:

Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04409483
• Other study ID #: Trascov
• Status: Withdrawn
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess whether lopinavir/ritonavir (or eventually other antiviral drugs) is effective at reducing the rate of hospitalization among confirmed COVID-19 cases treated as outpatients.

Description:

After being informed about the study and potential risks, all patients who meet all eligibility criteria and who give written informed consent will be randomized to receive standard care or standard care plus lopinavir/ritonavir (400mg/100mg twice daily for 14 days). Participants will receive daily visits from study staff for 15 days and be followed for a total of 28 days.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Suspect, probable or confirmed case of COVID-19
• Men and women aged =12 years, including pregnant and breastfeeding women
• SpO2 =93% on room air
• Signature of informed consent form

Exclusion Criteria:

• Medical indication for hospitalization at the time of enrolment
• Severe chronic liver disease
• Known infection with HIV
• Known allergy or severe intolerance to lopinavir/ritonavir
• Absolute contra-indication to lopinavir/ritonavir, including concomitant therapy with a medication whose metabolism is dependent on isoform CPY3A with a narrow therapeutic window (e.g., amiodarone, colchicine, simvastatin, lovastatin, etc.)
• Treatment with an antiviral medication in the 28 days prior to enrolment
• Dementia or other condition that interferes with active participation in data collection and obtaining informed consent

Related Conditions & MeSH terms

• Covid-19

Intervention

Drug:
• Lopinavir-Ritonavir Drug Combination
400mg/100mg taken orally twice daily for 14 days.

Combination Product:
• Standard Care
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Epicentre	Centre de Recherche Médicale et Sanitaire, Ministry of Public Health, Republic of Niger, Université Abdou Moumouni

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization or death	Hospitalization associated with desaturation (SpO2 =92%) or death due to any cause	15 days following randomization
Secondary	All-cause mortality	Death due to any cause	15 days following randomization
Secondary	All-cause mortality	Death due to any cause	28 days following randomization
Secondary	Time to hospitalization	Length of time between randomization and hospitalization associated with desaturation (SpO2 =92%)	28 days following randomization
Secondary	Length of hospitalization	Total duration of hospitalization associated with desaturation (SpO2 =92%)	28 days following randomization
Secondary	Admission to intensive care	Proportion of participants admitted to an intensive care unit	28 days following randomization
Secondary	Adverse events	Proportion of participants having an adverse event	28 days following randomization
Secondary	Serious adverse events	Proportion of participants having a serious adverse event	28 days following randomization