Evaluation of Additional Treatments for COVID-19: a Rando... | NCT04409483

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

NCT04409483

Sponsor

Epicentre

Status

Withdrawn

Last Update Posted

Feb 10, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Covid-19

Interventions

Lopinavir-Ritonavir Drug Combination
Standard Care

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Epidemic dynamics

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Name	Class
Université Abdou Moumouni	UNKNOWN
Centre de Recherche Médicale et Sanitaire	OTHER
Ministry of Public Health, Republic of Niger	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Care	Active Comparator	Standard care for COVID-19 according to the national guidelines of Niger	Combination Product: Standard Care
Standard Care plus lopinavir/ritonavir	Experimental	Standard care for COVID-19 according to the national guidelines of Niger plus lopinavir/ritonavir	Drug: Lopinavir-Ritonavir Drug Combination Combination Product: Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lopinavir-Ritonavir Drug Combination	Drug	400mg/100mg taken orally twice daily for 14 days.	Standard Care plus lopinavir/ritonavir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalization or death	Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause	15 days following randomization

Secondary Outcomes

Measure	Description	Time Frame
All-cause mortality	Death due to any cause	15 days following randomization
All-cause mortality	Death due to any cause	28 days following randomization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca F Grais	Epicentre	Study Director
Eric Adehossi	Hôpital Général de Référence de Niamey	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified patient data will be shared with local and international authorities.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Data will become fully accessible after primary publication of results.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C558899	lopinavir-ritonavir drug combination
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided