Status:
COMPLETED
A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19
Lead Sponsor:
Sanofi
Conditions:
Corona Virus Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Primary Objective: To evaluate the effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by C-reactive protein (CRP) levels in adult patients hospitalized with se...
Detailed Description
Study duration per participant is approximatively 32 days including a 14-day treatment period
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participant must be ≥18 years and ≤80 years of age inclusive, at the time of signing the informed consent.
- Hospitalized (or documentation of a plan to admit to the hospital if the participant is in an emergency department) with evidence of COVID-19 lung disease diagnosed by chest radiograph, chest computed tomography or chest auscultation (rales, crackles) and with severe disease defined as follows: The participant requires supplemental oxygen administered by nasal cannula, simple face mask, or other similar oxygen delivery device (ie, increase in oxygen requirement following SARS-CoV-2 infection).
- SARS-CoV-2 infection confirmed by RT-PCR, or other commercial or public health assay in any specimen, within 3 weeks prior to randomization, and no alternative explanation for current clinical condition.
- At time of randomization, have demonstrated laboratory signs consistent with systemic inflammation.
- Male and/or female participants, including women of childbearing potential (WOCBP).
- Capable of giving signed informed consent.
- Exclusion criteria:
- In the opinion of the investigator, unlikely to survive after 48 hours, or unlikely to remain at the investigational site beyond 48 hours
- Participants requiring use of invasive or non-invasive positive pressure ventilation at randomization.
- Presence of significant liver enzyme abnormalities, thrombocytopenia or anemia at screening.
- Any prior or concurrent use or plans to receive during the study period of immunomodulatory therapies (other than interventional drug) at screening.
- Use of chronic systemic corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day at screening.
- Exclusion criteria related to tuberculosis (TB) and non-tuberculous mycobacterial (NTM) infections.
- Participants with suspected or known active systemic bacterial or fungal infections within 4 weeks of screening.
- Pregnant or breastfeeding women.
- In the opinion of the study investigator, might confound the results of the study or pose an undue risk to the safety of the participant.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04469621
Start Date
July 17 2020
End Date
October 23 2020
Last Update
September 23 2025
Active Locations (10)
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1
Investigational Site Number 0320001
Caba, Argentina, 1430
2
Investigational Site Number 0760003
Porto Alegre, Brazil, 90035 003
3
Investigational Site Number 0760001
São José do Rio Preto, Brazil, 15090-000
4
Investigational Site Number 0760002
São Paulo, Brazil, 04321-120