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

  • STATUS
    Recruiting
  • participants needed
    67
  • sponsor
    Sanofi
Send
Updated on 5 August 2020
See if I qualify
ct scan
vasopressor
thrombolytic
covid-19
SARS
chest radiograph
coronavirus infection
auscultation
thrombolytic therapy
acute respiratory syndrome (sars)

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 severe COVID-19

Secondary Objectives:

  • To evaluate the time to onset of effect of SAR443122 relative to the control arm on the hyperinflammatory state as measured by CRP levels
  • To evaluate the time to onset of effect of SAR443122 relative to the control arm on oxygenation status
  • To evaluate the effect of SAR443122 relative to the control arm on oxygenation status
  • To evaluate the effect of SAR443122 relative to the control arm on total duration of supplemental oxygen requirement
  • To evaluate the effect of SAR443122 relative to the control arm on length of ventilator support needed
  • To evaluate the effect of SAR443122 relative to the control arm on laboratory markers of severe COVID-19
  • To evaluate the effect of SAR443122 relative to the control arm on mortality
  • To evaluate the effect of SAR443122 relative to the control arm on need for thrombolytic therapy
  • To evaluate the effect of SAR443122 relative to the control arm on need for vasopressor treatment
  • To evaluate the safety of SAR443122 as compared to the control arm up to End of Study

Description

Study duration per participant is approximatively 32 days including a 14-day treatment period

Details
Condition Corona Virus Infection
Age 18years - 80years
Treatment Placebo, SAR443122
Clinical Study IdentifierNCT04469621
SponsorSanofi
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

ct scan
vasopressor
thrombolytic
covid-19
SARS
chest radiograph
coronavirus infection
auscultation
thrombolytic therapy
acute respiratory syndrome (sars)

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.