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BIO101 in Prevention of Respiratory Deterioration in Hospitalized Patients With COVID-19 Pneumonia (Severe)
NCT04472728Phase 3
Key facts
- Status
- Terminated
- Start
- Aug 2020
- Primary completion
- Jun 2022
- Countries
- 5
- Sponsor
- Biophytis
- Modality
- Small Molecules
- Drugs
- 20-hydroxyecdysone
- Conditions
- COVID-19 pneumonia
01
Overview
Phase 3, randomised, double-blind trial in COVID-19 pneumonia comparing BIO101 with Placebo (2 arms). Primary endpoint: Percentage of Participants Experiencing Negative Events up to 28 days. Started Aug 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
BIO101
BIO101 350 mg twice daily (BID)
Placebo
Placebo capsules
03
Who it enrols
Hospitalized patients aged 45 and older (55 and older in France) with confirmed COVID-19 infection, evidence of pneumonia, and respiratory decompensation.
04
Endpoints
Primary
Percentage of Participants Experiencing Negative Events
Secondary
Number of Participants Experiencing Positive Events
Change From Baseline in Saturation by Pulse Oximetry (SpO2)/Fraction of Inspired Oxygen (FiO2) Ratio
Change From Baseline in Oxygen Saturation in Arterial Blood as Measured by SpO2
Number of Participants Experiencing All-cause Mortality
Time to Reach a Negative Event
Time to Reach a Positive Event
Change From Baseline in National Early Warning Score 2 (NEWS2)
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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