MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients
Status:
Active, not recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
A Combined Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects/Phase
II, Randomized, Double-blind, Placebo-Controlled, Multi-center Study in Hospitalized Patients
Infected with Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics,
Pharmacodynamics and Efficacy of MRG-001 (Plerixafor Plus Low-dose Tacrolimus)
Part A: To determine the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics
(PD) profiles of MRG-001 in healthy subjects.
Part B: Time to clinical improvement from randomization by at least 2 points on the 8-point
ordinal scale of WHO clinical improvement scale assessed at 14, 28 and 60 days
(1=Asymptomatic, no limitations of activities; 8=death).