Back to resultsEvaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger (TRASCOV)
Primary Purpose
Covid-19
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lopinavir-Ritonavir Drug Combination
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care
Standard Care plus lopinavir/ritonavir
Arm Description
Standard care for COVID-19 according to the national guidelines of Niger
Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
Outcomes
Primary Outcome Measures
Hospitalization or death
Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
Secondary Outcome Measures
All-cause mortality
Death due to any cause
All-cause mortality
Death due to any cause
Time to hospitalization
Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
Length of hospitalization
Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
Admission to intensive care
Proportion of participants admitted to an intensive care unit
Adverse events
Proportion of participants having an adverse event
Serious adverse events
Proportion of participants having a serious adverse event
Full Information
NCT ID
NCT04409483
First Posted
May 28, 2020
Last Updated
February 9, 2021
Sponsor
Epicentre
Collaborators
Université Abdou Moumouni, Centre de Recherche Médicale et Sanitaire, Ministry of Public Health, Republic of Niger
1. Study Identification
Unique Protocol Identification Number
NCT04409483
Brief Title
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Acronym
TRASCOV
Official Title
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Epidemic dynamics
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epicentre
Collaborators
Université Abdou Moumouni, Centre de Recherche Médicale et Sanitaire, Ministry of Public Health, Republic of Niger
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard care for COVID-19 according to the national guidelines of Niger
Arm Title
Standard Care plus lopinavir/ritonavir
Arm Type
Experimental
Arm Description
Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir
Intervention Type
Drug
Intervention Name(s)
Lopinavir-Ritonavir Drug Combination
Intervention Description
400mg/100mg taken orally twice daily for 14 days.
Intervention Type
Combination Product
Intervention Name(s)
Standard Care
Intervention Description
Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
Primary Outcome Measure Information:
Title
Hospitalization or death
Description
Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause
Time Frame
15 days following randomization
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Death due to any cause
Time Frame
15 days following randomization
Title
All-cause mortality
Description
Death due to any cause
Time Frame
28 days following randomization
Title
Time to hospitalization
Description
Length of time between randomization and hospitalization associated with desaturation (SpO2 ≤92%)
Time Frame
28 days following randomization
Title
Length of hospitalization
Description
Total duration of hospitalization associated with desaturation (SpO2 ≤92%)
Time Frame
28 days following randomization
Title
Admission to intensive care
Description
Proportion of participants admitted to an intensive care unit
Time Frame
28 days following randomization
Title
Adverse events
Description
Proportion of participants having an adverse event
Time Frame
28 days following randomization
Title
Serious adverse events
Description
Proportion of participants having a serious adverse event
Time Frame
28 days following randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca F Grais
Organizational Affiliation
Epicentre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eric Adehossi
Organizational Affiliation
Hôpital Général de Référence de Niamey
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified patient data will be shared with local and international authorities.
IPD Sharing Time Frame
Data will become fully accessible after primary publication of results.
Learn more about this trial
Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
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