Long Haul COVID Rehabilitation & Recovery Research Program (LHCRehab)

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status: Enrolling

Conditions: Post-Acute COVID-19 Syndrome

Treatments: Other: Virtual vs On Site Pulmonary Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05398692

032588-01

Details and patient eligibility

About

The purpose of the study is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Long Haul COVID (LHC).

Full 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 Long Haul COVID (LHC).

1.2 State the hypotheses to be tested.

Long Haul COVID Patients who enroll and complete a 10 week program of Physiologic and Psychological Rehabilitation will have reduced Long Haul COVID Symptoms, Improved Physical Status, Reduced Inflammatory Markers, and Augmented Psychological Well Being.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Long Haul COVID 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 criteria

• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

+ PEM

Active Comparator group

Description:

Patients who experience Post Exertional Malaise (PEM) will receive 10 weeks of virtual rehabilitation.

Treatment:

Other: Virtual vs On Site Pulmonary Rehabilitation

No PEM

Experimental group

Description:

Patients who do not experience Post Exertional Malaise (PEM) will receive 10 weeks of traditional pulmonary rehabilitation.

Treatment:

Other: Virtual vs On Site Pulmonary Rehabilitation