Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

• ClinicalTrials.gov Identifier: NCT04604678
• Recruitment Status: Withdrawn
• First Posted: October 27, 2020
• Last Update Posted: October 4, 2022
• Sponsor: AgelessRx
• Information provided by (Responsible Party): AgelessRx

Tracking Information

• First Submitted Date: October 26, 2020
• First Posted Date: October 27, 2020
• Last Update Posted Date: October 4, 2022
• Estimated Study Start Date: February 2021
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2020)

• Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN [ Time Frame: 1 week ]
  Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
• Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN [ Time Frame: 2 weeks ]
  Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.

Original Primary Outcome Measures (submitted: October 26, 2020)

• Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN [ Time Frame: 1 week ]
  Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale
• Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN [ Time Frame: 2 weeks ]
  Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale

Current Secondary Outcome Measures (submitted: October 26, 2020)

• Reduction in recovery time from COVID-19 [ Time Frame: 4 weeks ]
  Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
• Reduction in hospitalizations [ Time Frame: 4 weeks ]
  Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
• Reduction in requirement of additional treatment due to COVID-19 [ Time Frame: 4 weeks ]
  Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group
• Reduction in mortality [ Time Frame: 4 weeks ]
  Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
• Official Title: Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects
• Brief Summary: Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
• Detailed Description: The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• Drug: Metformin
  Metformin at 1500 mg/day
• Drug: Naltrexone
  Naltrexone at 4.5 mg/day (LDN)
  Other Name: LDN

Study Arms

• Experimental: Treatment with Metformin and LDN
  Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
  Interventions:

  • Drug: Metformin
  • Drug: Naltrexone
• No Intervention: Regular health care comparison group
  Patients will receive regular health care and will serve as a control group.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 3, 2022): 0
• Original Estimated Enrollment (submitted: October 26, 2020): 80
• Estimated Study Completion Date: October 2021
• Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Age 30-70
• Any sex
• Any ethnicity
• Adequate cognitive function to be able to give informed consent
• Technologically competent to complete web forms and perform video calls with the PI
• Positive PCR (polymerase chain reaction) test result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) within the last 10 days
• At least two COVID-19 symptoms as assessed by laboratory or patient self-reporting started within the last 3 days
• Willing to fill out regular questionnaires
• Willing to take metformin and LDN

Exclusion Criteria:

• Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement)
• Hypoglycemia
• Currently on drugs for COVID-19
• Hospitalization for COVID-19
• (Suspected) pregnancy or breastfeeding
• Active cancer
• Uncontrolled mental health issues
• On any medication with major interactions with metformin or LDN
• Taking opioid analgesics, or being treated for opioid addiction/recovery
• Opioid dependence or withdrawal syndrome
• Known sensitivity to metformin or naltrexone
• Current users of metformin or naltrexone

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04604678
• Other Study ID Numbers: ALRx003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AgelessRx
• Original Responsible Party: Same as current
• Current Study Sponsor: AgelessRx
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sajad Zalzala, MD; AgelessRx
• Principal Investigator: Sajad Zalzala, MD; AgelessRx

• PRS Account: AgelessRx
• Verification Date: October 2022