A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial

Launched by CARDRESEARCH · Nov 10, 2023

Keywords

ClinConnect Summary

The REVIVE Trial is a research study that aims to find out how effective certain treatments are for people suffering from Long COVID-19 syndrome, a condition where symptoms persist for more than 12 weeks after a COVID-19 infection. This trial is looking for participants aged 18 and older who have had a confirmed case of COVID-19 and are experiencing significant fatigue. To be eligible, participants must not currently be hospitalized and should have specific health indicators, like a stable heart rate and oxygen levels.

If you choose to participate, you will be randomly assigned to receive either the study treatment or a placebo (a non-active treatment) without knowing which one you received. The goal is to see if the treatments can help reduce fatigue and improve daily functioning. As part of the study, you will need to follow some procedures and keep track of your symptoms over time. The study is currently recruiting participants, and your involvement could contribute to a better understanding of Long COVID and potential treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older at the time of screening.
• • 2. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent (where approved locally and nationally).
• • 3. Previous confirmed case of SARS-CoV-2 infection (e.g., reports having a positive nucleic acid amplification test or a professional-use SARS-CoV-2 rapid antigen diagnostic test or positive self-test).
• • 4. Participants with a clinical picture compatible with LONG COVID according to international definitions: (www.nice.org.uk/guidance/ng188, https://www.who.int/publications/i/item/WHO-2019-nCoV-Post_COVID -19_condition-Clinical_case_definition-2021.1), and fatigue symptoms with an average score of at least 03 on the Fatigue Analog Scale (FSS)
• • 5. Not currently hospitalized or requiring hospitalization, or having been hospitalized in an intensive care center at the time of the COVID-19 episode.
• 6. Participants with the following vital data:
• • 1. Heart Rate between 55 and 100 bpm;
• • 2. Temperature below 38o C;
• • 3. Oxygen saturation ≥ 95%.
• • 7. Patients of childbearing potential or with partners of childbearing potential must agree to use adequate contraception during the study and up to 90 days of follow-up.
• • 8. The symptoms of fatigue cannot be attributed to any other cause (in the researcher's opinion).
• • 9. Willingness to follow all study procedures.
• Exclusion Criteria:
• • 1. Known acute SARS-CoV-2 infection;
• • 2. Inability to understand the content of the Informed Consent Form or to follow the study procedures;
• • 3. Known previous diagnosis of malignant encephalomyelitis/chronic fatigue syndrome, unrelated to SARS-CoV-2 infection;
• • 4. Known pre-existing dysautonomia, unrelated to SARS-CoV-2 infection;
• • 5. Diabetes mellitus (exclusion criteria for the Metformin and Metformin Placebo arm);
• • 6. Known stroke within 3 months prior to screening;
• • 7. Known severe anemia, defined as \< 8 g/dl;
• • 8. Body Mass Index (BMI) \> 35.
• • 9. Known diagnosis of Lyme disease;
• • 10. Any use of illicit drugs not related to marijuana within 30 days prior to informed consent;
• • 11. Pregnant women or women of childbearing age who do not agree to practice an effective method of contraception within 90 days from the date of signing this consent form;
• • 12. Breastfeeding women;
• • 13. Participants using serotonin reuptake inhibitors (donepezil, fluoxetine, escitalopran, parorexitin);
• • 14. Participants chronically using any of the medications under evaluation (metformin and fluvoxamine);
• • 15. Severe current comorbid psychiatric disorder (e.g., clinical depression, anxiety, sleep disorder, eating disorder, substance abuse), uncontrolled and associated with significant symptoms or requiring the use of a medication contraindicated in this research ;
• • 16. Clinical history of moderate to severe hepatic impairment or liver cirrhosis with Child-Pugh classification C or greater;
• • 17. Clinical history of severe lung disease with significant limitation of activities;
• • 18. Inability of the participant to give consent or adhere to the procedures proposed in the study;
• • 19. Taking medications which are known to cause a known side effect of chronic fatigue;
• • 20. Known hypersensitivity and/or intolerance to Fluvoxamine or Metformin;
• • 21. Any clinical condition which, in the investigator's opinion, may prevent participation in this research.