Homeopathic Treatment of Post-acute COVID-19 Syndrome

Study Overview
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Brief Summary
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To determine whether an individually prescribed homeopathic medicine has an effect greater than a placebo and is a viable treatment option to improve fatigue and quality of life for patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to achieve this goal by conducting a clinical trial that is scientifically rigorous and clinically relevant. Expected results of this pilot study will be to obtain sufficient experience and preliminary feasibility data to justify a larger clinical trial of this hypothesis.

Detailed Description
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The researchers objectives for the study are to: 1) identify efficient means of recruiting subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed for this syndrome, and 6) determine whether there is a measurable effect size difference or positive trend in reduction of symptoms in patients treated with homeopathy.

Official Title
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Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial

Conditions
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Post-acute Covid-19 Syndrome

Intervention / Treatment
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* Drug: Homeopathic Medication
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-64 Any ethnicity Adequate cognitive function to be able to give informed consent Technologically competent to complete web forms and perform video calls Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) Persistent fatigue for a minimum of 60 days since diagnosis of Covid-19. A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment Willing to fill out regular questionnaires Willing to use homeopathic medicines Exclusion Criteria: Clinically significant kidney, heart, or hepatic impairment as determined by clinical judgment Previous hospitalization in ICU for Covid-19 Diagnosis of Chronic Fatigue Syndrome, Fibromyalgia, or Lyme disease prior to Covid-19 Chronic psychiatric illness or neurological illness prior to Covid-19 diagnosis Taking opioid analgesics, opioid dependence or undergoing treatment for substance abuse or addiction Taking steroid medication or immunosuppressive medications Suspected or confirmed pregnancy or breastfeeding Active cancers Current treatment by a homeopathic practitioner Initiation of another treatment for Long Covid within the past 2 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Homeopathic Treatment Group<br>Individualized homeopathic medicines on impregnated lactose pellets will be prescribed to each participant based on the totality of their physical, emotional, and mental symptoms. All medicines prescribed are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) as outlined in the Food, Drug, and Cosmetics Act of 1939 | Drug: Homeopathic Medication<br>* Homeopathic medicines are prepared according to standardized methods as specified by the Homeopathic Pharmacopoeia of the United States (HPUS), which was mandated by Congress to regulate the manufacture of homeopathic medicines as part of the Food, Drug, and Cosmetics Act of 1939. All homeopathic medicines prescribed in this study must be found in the HPUS. For a complete list of homeopathic medicines, contact the researchers.<br>|
| Placebo Comparator: Placebo Group<br>Identical lactose pellets in size, odor, and taste without the impregnated homeopathic medicines. | Other: Placebo<br>* Inert lactose pellets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Assessment Scale (FAS) | The Fatigue Assessment Scale (FAS) is a 10-item self-report scale evaluating symptoms of chronic fatigue. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue. Less than 22 indicates normal (i.e. healthy) levels of fatigue between 22 and 34 indicates mild-to-moderate fatigue 35 or more indicates severe fatigue (Hendricks et al., 2018). | Baseline, 4, 8 and 12 weeks | 
| SF-36 Physical Composite Score (PCS) | Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. | Baseline and 4, 8, and 12 weeks | 
| SF-36 Mental Composite Score (MCS) | Quality of life was evaluated by using the the RAND 36-Item Short Form Health Survey (SF-36), which was completed by participants throughout the study. The SF-36 evaluates 8 health concepts and can be aggregated into two summary scores: the Physical (PCS) and Mental (MCS) Component Summary scores. Each item of the scale ranges from 0-100, where high values mean good health status, while lower values indicate poor health status. Items are averaged together to create PCS or MCS scale scores. ￼ | Baseline and 4, 8, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool for assessing depression The PHQ-9 scores each of the 9 DSM-IV depression criteria as 0 (not at all) to 3 (nearly every day). PHQ-9 scores range from 0 to 27, with scores of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depression, respectively. | Baseline and 12 weeks | 
| Measure Yourself Medical Outcomes Profile Symptom #1 | The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health. | Baseline and 12 weeks | 
| Measure Yourself Medical Outcomes Profile Symptom #2 | The Measure Yourself Medical Outcomes Profile (MYMOP) is a problem specific and individualized measure that captures what patients consider are the two most important symptoms associated with their condition (Long COVID) and an activity of daily living that is affected by these symptoms. The symptom is then rated by the patient on a scale 0-6 where higher values mean poor health and lower values indicate good health. | Baseline and 12 weeks | 
| Patient Doctor Depth of Relationship (PDDR) | The Patient Doctor Depth of Relationship (PDDR) scale is an eight item, patient self-completed questionnaire designed to measure patient-doctor relational depth. A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Covid