A Phase 2 interventional study of RP7214 + Standard of care (SOC) and Placebo + Standard of care (SOC) in SARS-CoV-2 Infection, sponsored by Rhizen Pharmaceuticals SA. Completed at 16 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-21.
Sponsored by Rhizen Pharmaceuticals SA · Phase 2, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 163 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Rhizen Pharmaceuticals SA is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: RP7214 + Standard of care (SOC)
Drug: Placebo + Standard of care (SOC)
RP7214 tablets will be administered orally twice a day for 14 days
Placebo will be administered orally twice a for 14 days
Proportion of patients requiring Covid-19 related hospitalization by Day 15.
Time frame: 15 days
Change from baseline in SARS-CoV-2 viral load at Days 3, 7 and 15 by quantitative RT-PCR test
Time frame: 15 days
Time to symptom resolution in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom resolution
Time frame: 15 days
Time to symptom improvement in patients receiving RP7214 as compared to placebo
Time frame: 15 days
Proportion of patients demonstrating symptom improvement
Time frame: 15 days
Adverse Events (AEs) as assessed by laboratory tests, vital signs and physical examination.
Time frame: 15 days
Change in the disease-specific inflammatory markers (Ferritin, C-reactive protein (CRP), D-dimer, neutrophil to lymphocyte/CD8+ ratio, LDH, IL-6) as compared to baseline.
Time frame: 15 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Rhizen Pharmaceuticals SA