Status:
TERMINATED
Long COVID-19 Rehabilitation & Recovery Research Program
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Conditions:
Post-Acute COVID-19 Syndrome
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The purpose of the study is to assess the physiologic, immunologic, and mental health effects of an exercise and pulmonary rehabilitation program on patients with Long COVID-19 (LC).
Detailed Description
1.0 Objectives 1.1 Describe the purpose, specific aims, or objectives. The purpose is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Lo...
Eligibility Criteria
Inclusion
- Long COVID-19 Infection (Documented by PCR or patient report)
- Age \>= 18 years old.
- At least 12 weeks since the initial COVID Infection.
- One or more of the following symptom/signs: Fatigue, Dyspnea, Exercise Intolerance, Post Exertional Malaise and/or Difficulty Breathing.
- Able to perform a cardiopulmonary exercise test.
Exclusion
- Patients is not able to perform technically acceptable pulmonary function tests and symptom-limited cardiopulmonary cycle ergometry tests.
- Patients who desaturate to SpO2 \<80% on screening incremental exercise testing.
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
- Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to screening visit (Visit 1).
- Pregnant or nursing women.
- Women of childbearing potential who are not using a highly effective method of birth control. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Patients who are currently participating in another interventional study.
- Malignancy for which the patient has undergone resection, radiation therapy, or chemotherapy within the last 2 years
- Any other significant disease than COVID-19 which, in the opinion of the investigator, may i) put the patient at risk because of participation in the study, ii) influence the results of the study (e.g. Insulin or testosterone therapy, systemic corticosteroids, HIV, etc), iii) cause concern regarding the patient's ability to participate in the study.
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05398692
Start Date
February 2 2022
End Date
December 31 2023
Last Update
September 22 2025
Active Locations (1)
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1
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90509