COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05595369

Rachel E Olson, RN MS MBA PMP

recoverresearch@duke.edu

2022-10-27

Not recruiting

RCT

Randomized

Adaptive

Blind label

unclear

Treatment

inclusion criteria: ≥ 18 years of age at the time of enrollment previous suspected, probably or confirmed sars-cov-2 infection, as defined by the pan american health organization* *suspected and probable cases will only be allowed if they occurred before may 1, 2021, and will be limited to 10% of the study population. otherwise, confirmed cases are required. suspected case of sars-cov-2 infection - three options, a through c: a. a person who meets the clinical or epidemiological criteria. clinical criteria: acute onset of fever and cough (influenza-like illness) or acute onset of any three or more of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. epidemiological criteria: contact of a probable or confirmed case or linked to a covid-19 cluster; or b. acute respiratory infection with history of fever or measured fever of ≥ 38°c; and cough; with onset within the last 10 days; and who requires hospitalization); or c. with no clinical signs or symptoms, nor meeting epidemiologic criteria with a positive professional use or self-test sars-cov-2 antigen-rapid diagnostic test. probable case of sars-cov-2 infection: a. a patient who meets clinical criteria above and is a contact of a probable or confirmed case or is linked to a covid-19 cluster. confirmed case of sars-cov-2 infection - two options, a through b: a. a person with a positive nucleic acid amplification test, regardless of clinical criteria or epidemiological criteria; or b. meeting clinical criteria and/or epidemiological criteria (see suspect case a). with a positive professional use or self-test sars-cov-2 antigen-rapid diagnostic test. at least two moderate symptoms from the same symptom cluster or one severe cluster-associated symptom identified via the cluster targeted covid-19 symptom questions (ctcsq), with participant identifying new symptoms since covid-19 illness and having persisted for at least 12 weeks meeting pro symptom cluster criteria for at least one symptom cluster willing and able to provide informed consent, complete the surveys, clinical assessments, and return for all of the necessary follow-up visits

an individual who meets any of the following criteria will be excluded from participation in this study. refer to appendices for additional appendix-level criteria: known active acute sars-cov-2 infection ≤ 4 weeks from consent known severe anemia, defined as < 8 g/dl meeting the following symptom cluster exclusion for all eligible clusters*: a. cognitive dysfunction: known stroke that resulted in cognitive impairment within 3 months of enrollment b. autonomic dysfunction: atrial fibrillation or significant cardiac arrhythmia, more than moderate alcohol consumption**, pre-existing sustained severe hypertension (bp> 180/110 mmhg in the sitting position) c. exercise intolerance: i. any of the following within 4 weeks of consent - an acute myocardial infarction or unstable angina, uncontrolled arrhythmias causing symptoms or hemodynamic compromise, acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema), acute pulmonary embolism, suspected dissecting aneurysm, severe hypoxemia at rest, any acute or chronic disorder that may affect exercise performance ii. if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate) *participants who are eligible for > 1 cluster must meet all inclusion and no exclusion criteria for an individual symptom cluster. if not, they will be excluded from that individual symptom cluster. ** defined as greater than 2 drinks a day for men and 1 drink a day for women. a drink is equivalent to 12 ounces of beer (5% alcohol content), 8 ounces of malt liquor (7% alcohol content), 5 ounces of wine (12% alcohol content), 1.5 ounces or a "shot" of 80-proof (40% alcohol content) distilled spirits or liquor (e.g., gin, rum, vodka, whiskey). 21 known diagnosis of lyme disease any non-marijuana illicit drug use within 30 days of informed consent current or recent use (within the last 14 days) of study intervention* known allergy/sensitivity or any hypersensitivity to components of the study intervention (s) or control* known contraindication(s) to study intervention(s), inability to discontinue symptomatic medications for the identified time periods moderate or severe immunocompromised patients, such as those described in the nih covid-19 treatment guidelines (https://www.covid19treatmentguidelines.nih.gov/ special populations/immunocompromised/) enrolled into another study intervention appendix in this platform protocol*** ***participants may re-enroll in the trial for a different study intervention appendix if they have completed an appropriate washout period and efficacy has been determined for the appendix in which they were previously enrolled. any condition that would make the participant, in the opinion of the investigator, unsuitable for the study if only one study intervention appendix is open at the time of enrollment. if multiple study intervention appendices are open, a participant may be excluded from any study intervention appendix based on contraindications listed in the study intervention appendix, current use of study intervention, or known allergy/sensitivity/hypersensitivity and still remain eligible for the remaining study intervention appendices.

3

Kanecia Obie Zimmerman

18

100

None

Patients recovered from covid

N/A

900

Change in Autonomic dysfunction symptom cluster, as measured by the orthostatic hypotension questionnaire (OHQ);Change in Cognitive dysfunction symptom cluster, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function T-score;Change in Exercise intolerance symptom cluster, as measured by the Modified Depaul Symptom Questionnaire-Post Exertional Malaise (DSQ-PEM)

None

Phase 2

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