Promoteur(s) :
State University of New York at Buffalo
Recrutement : fermé
Centres participants
1
Dernière modification : 2025-03-04
DESCRIPTION DE L'ÉTUDE
Résumé de l'étude
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
Source : Importé depuis le centre
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 18 ans
maximum : 80 ans
Sexe(s) des participants
ALL
Source : Importé depuis le centre
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Lithium
Lithium 10mg po qd
Donnée non disponible
Inconnu
Placebo
Placebo identically matching the lithium pills
Donnée non disponible
Inconnu
Lithium
État du recrutement
unknown
Lithium 10mg po qd
Placebo
État du recrutement
unknown
Placebo identically matching the lithium pills
Données à jour depuis :
4 mars 2025
SITES ET CONTACTS
Centre principal
university at buffalo, the state university of new york
BUFFALO, NEW YORK, UNITED STATES
Recrutement local
—
FERMÉ
Dernière modification :
4 mars 2025
Données à jour depuis :
6 mars
Origine des données :
clinicaltrials.gov
1. Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
2. No fever for ≥4 weeks prior to enrollment.
3. Reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the PASC-Specific Symptom questionnaire beginning after infection with COVID-19.
4. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
5. Beck Depression Inventory II score \<24.
6. No change in any psychoactive or steroid medications for ≥30 days.
7. No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks.
8. Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks.
9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.
10. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.
11. No use of tobacco or marijuana products for \>6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
12. Not receiving or applying for disability payments or workman's compensation for long COVID.
13. Not pregnant or nursing or planning to get pregnant over the next two months.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Lithium
Lithium 10mg po qd
Donnée non disponible
Inconnu
Placebo
Placebo identically matching the lithium pills
Donnée non disponible
Inconnu
Lithium
État du recrutement
unknown
Lithium 10mg po qd
Placebo
État du recrutement
unknown
Placebo identically matching the lithium pills
Données à jour depuis :
4 mars 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
Source : Importé depuis le centre
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
1
centres
UNIVERSITY AT BUFFALO, THE STATE UNIVERSITY OF NEW YORK
Buffalo
NEW YORK, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Source d'information
Dernière modification :
4 mars 2025
Données à jour depuis :
6 mars
Origine des données :
clinicaltrials.gov