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

COVID-19 Clinical Trial

Official title:

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of MYMD1, a Novel Immuno-Metabolic Regulator, to Treat Depression in Patients With Post-Acute Sequelae of Coronavirus Disease-2019

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05242003
• Other study ID #: IRB00267613
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2022
• Source: Johns Hopkins University
• Contact: Mansoor Malik
• Phone: 4105509908
• Email: mmalik4[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Depression
• Depression, Anxiety
• Depressive Disorder
• Inflammation

Intervention

Drug:
• Placebo
Oral tablet, placebo once/day for 10 days
• 300mg MYMD-1
Two 150mg oral tablets, 300mg total once/day for 10 days
• 600mg MYMD-1
Four 150mg oral tablets, 600mg total once/day for 10 days

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	MyMD Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS is a 10-item scale that is sensitive to antidepressant efficacy. The ten constituent questions respectively assess: apparent sadness, reported sadness, feelings of tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel emotions, pessimistic thoughts, and suicidal thoughts. Each component is rated by the patient on a scale of 0 (none at all) to 6 (very severe), providing a maximum total score of 60. 0-10: Remission, 11-19: Mild depression, 20-29 moderate depression, 30-60: Severe depression.	Baseline and weekly, up to 1 month
Primary	Change in depressive symptoms as assessed by the Snaith-Hamilton Pleasure Scale (SHAPS)	The SHAPS consists of 14 confirmatory statements about enjoyable situations typically encountered in daily life cross-culturally. The scale is rated on a 4-point Likert scale: 0 = strongly disagree, 1 = disagree, 2 = agree, 3 = strongly agree, except for five reverse scored items. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more.	Baseline, Weekly, up to 1 month
Primary	Efficacy of MYMD1 at the proposed doses as assessed by number of serious complications	Outcome measure will compare the number of participants with or without serious complications using Fisher's exact test.	Up to 1 month
Primary	Safety of MYMD1 at the proposed doses assessed by number of adverse events	The analysis of safety will be done using a modified intention to treat approach considering all randomized and treated participants. Adverse events (AEs) experienced by treated participants in each study arm will be described separately. All the AEs that occur during the study will be included in the data lists and organized according to each patient. Events that are considered to be related to the treatment (possibly, probably, or definitely related to it) will also be included in a table. A table with the list of AEs according to maximum intensity will be provided.	Up to 1 month
Secondary	Immunomodulatory role of MYMD1 in ameliorating pro-inflammatory biomarker tumor necrosis factor alpha (TNFa) as assessed by TNFa level	TNFa is an inflammatory cytokine produced by macrophages/monocytes during acute inflammation and is responsible for a diverse range of signaling events within cells, leading to necrosis or apoptosis. Normal values are 75 +/- 15 picograms per milliliter (pg/mL).	Up to 1 month
Secondary	Immunomodulatory role of MYMD1 in ameliorating pro-inflammatory biomarker interleukin 6 (IL-6) as assessed by IL-6 level	IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, illness, and in patients with mood disorders. IL-6 is not present or is low in healthy individuals and exact reference ranges vary by lab, with an example normal reference range of 0.31 to 5.00 pg/mL.	Up to 1 month
Secondary	Immunomodulatory role of MYMD1 in ameliorating pro-inflammatory biomarker c-reactive protein (CRP) as assessed by CRP level	Most hospitalized patients with COVID-19 have elevated C-Reactive Protein (CRP). CRP increases when inflammation is present and can be measured with a high sensitivity-CRP (hs-CRP) test. Hs-CRP values <1 milligram per liter (mg/L) indicate no inflammation while values >10mg/L indicate inflammation.	Up to 1 month