Status and phase
Conditions
About
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).
Enrollment
Sex
Ages
Volunteers
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
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Data sourced from clinicaltrials.gov
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