OSVID STUDY

Not Applicable

Not yet recruiting

• Conditions: -B342 Coronavirus infection, unspecified site; Coronavirus infection, unspecified site; B342

• Registration Number: PER-093-20
• Lead Sponsor: Fulcrum Therapeutics INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Able and willing to provide written informed consent.
2. Willing and able to comply with all study procedures.
3. Age ≥50 years at time of screening.
4. Confirmed infection with SARS-CoV-2 virus at or before the baseline visit (by polymerase
chain reaction [PCR] testing).
5. ≤7 days to the time of randomization from the time of collection of the specimen that tested
positive for SARS-CoV-2 virus.
6. Hospitalization at the time of the baseline visit.
7. ≥90% oxygen saturation on room air and/or ≥94% oxygen saturation on oxygen
administration at 2 L/min by nasal canula at the baseline visit.
8. Radiographic (X-ray or computed tomography scan, per local standard of care) evidence of
pulmonary involvement consistent with COVID-19 at screening or baseline, per the judgment of the investigator.
9. Clinical syndrome consistent with COVID-19 at screening, per the judgment of the investigator
10. CRP at screening >15 mg/L (ie, >1.5 mg/dL) on local laboratory testing.
11. Agrees to practice an approved method of birth control as follows (as applicable to local guidelines and regulations for sites outside the United States)

Exclusion Criteria

1. Inability to take oral medication at screening or baseline visit.
2. Evidence at screening or baseline of critical COVID-19 disease
3. Positive pregnancy test at screening for women of childbearing potential.
4. Lactating female at baseline for women of childbearing potential.
a. Note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose.
5. ≥5 × upper limit of normal (ULN) for alanine or aspartate aminotransferases or total bilirubin >1.5 × ULN at screening or known history of Child-Pugh Class C, hepatitis B or C, or HIV infection.
6. Glomerular filtration rate <30 mL/min/1.73 m2 at screening.
7. QTcF >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening.
8. Significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
9. Has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (IL)-6 inhibitors, tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents, and Janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period.
10. Treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or SOC any time during the study period.
11. Recent (within 30 days) or current participation in other COVID-19 therapeutic trials or expanded access programs.
12. Prior or current participation in COVID-19 vaccine trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified