A Phase 1b Trial to Evaluate Safety and Effect of SAR443122 on Immune System in Severe COVID-19

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.