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Trial - NCT04604678


Column Value
Trial registration number NCT04604678
Full text link
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04604678

First author
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

None

Registration date
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-10-27

Recruitment status
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

AgelessRx

Inclusion age min
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

30

Inclusion age max
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Oct. 5, 2022, 7:30 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN;Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN

Notes
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 27, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1628, "treatment_name": "Metformin+naltrexone", "treatment_type": "Metabolic agents+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]