Overview

Assessing the Safety and Efficacy of MYMD1 to Treat Depression in Patients With Post-Acute Sequelae of Coronavirus Disease-2019 (PASC)

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase II, Double-Blind, Randomized, Placebo-Controlled Study to evaluate the effects of the drug MYMD1, a novel Immuno-Metabolic Regulator, for its antidepressant and antianxiety properties, in addition to its anti-inflammatory effects, in patients with Post-Acute Sequelae of Coronavirus Disease-2019. The investigators' hope is that this drug will help treat the depressive and anxiety symptoms in post-COVID-19 patients and any post-COVID-19 inflammatory complications. The total duration of the study will be a maximum of 40 days-involving enrollment (1 day), an active treatment phase (10 days) during which participants will either receive 300mg of MYMD1, 600mg of MYMD1, or a placebo, and a remote monitoring phase (28 days).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
MyMD Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

- 18+ years of age and able to provide informed consent

- Post-acute phase COVID-19 patient with mild, moderate, severe or critical course.

- Montgomery-Asberg Depression Rating Scale (MADRS) Scores > 20, indicating moderate to
severe depression

- Peripheral CRP level ≥5mg/L and/or phenotypic (e.g. comorbid inflammatory bowel
disorder, rheumatologic disorder or metabolic syndrome) evidence of inflammatory
activation

Exclusion Criteria:

- Unable to give informed consent and have no legal representative

- Prisoner/institutionalized patient

- Under age 18

- Female subjects who identify as pregnant, self-reported positive pregnancy testing, or
who are breastfeeding during the study period

- Inability to tolerate oral medications

- Any concurrent treatments (e.g. Dexamethasone or Monoclonal Antibodies) that would
make patients unsuitable for inclusion in the view of treatment team

- Current smoker or smokeless tobacco user, no use of tobacco with 30 days of study
entry