NCT04409483

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

May 28, 2020

Last Update Submit

February 9, 2021

Conditions

Covid-19

Outcome Measures

Primary Outcomes (1)

  • Hospitalization or death

    Hospitalization associated with desaturation (SpO2 ≤92%) or death due to any cause

    15 days following randomization

Secondary Outcomes (7)

  • All-cause mortality

    15 days following randomization

  • All-cause mortality

    28 days following randomization

  • Time to hospitalization

    28 days following randomization

  • Length of hospitalization

    28 days following randomization

  • Admission to intensive care

    28 days following randomization

  • +2 more secondary outcomes

Study Arms (2)

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 CombinationCombination Product: Standard Care

Interventions

Lopinavir-Ritonavir Drug CombinationDRUG

400mg/100mg taken orally twice daily for 14 days.

Standard Care plus lopinavir/ritonavir
Standard CareCOMBINATION_PRODUCT

Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily

Standard CareStandard Care plus lopinavir/ritonavir

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Interventions

lopinavir-ritonavir drug combinationStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Rebecca F Grais

    Epicentre

    STUDY DIRECTOR

  • Eric Adehossi

    Hôpital Général de Référence de Niamey

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 1, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become fully accessible after primary publication of results.