Clinical trial NCT04846010: Recovering Damaged Cells for Sequelae Caused by COVID-19, SARS-CoV-2
Official title: Treating Sequalae Caused by Post-acute Sequelae of SARS (Severe Acute Respiratory Syndrome)-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Sequelae of; Infection
Post Infection Glomerulonephritis
Post-Infectious Peripheral Neuralgia
Post-Infectious Disorder (Disorder)
Post-Infectious Arthritis
Post-Infectious Polyneuritis
Post-Infectious Parkinsonism
Post-Infectious Hypothyroidism
Post Infectious Osteoarthritis
Anxiety Disorders
Depression
Depression, Anxiety
Depression, Bipolar
Insomnia
GERD
Gastro Esophageal Reflux
Hepatitis
Glomerulonephritis
Keywords: treatment of Covid-19 virus infection
COVID stress syndrome
COVID19 stress syndrome
sequelae
sequels
loss of smell
loss of taste
emotion disorder
panic disorder
Post-Traumatic Stress Disorder (PTSD)
Depression
Anxiety
Heartburn
GERD
Gastroesophageal reflux disease
Sleep Disorders
Lead sponsor: All Natural Medicine Clinic, LLC
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This clinical study designed with a sequential assignment: participants receive their medical herbs depending on their pathological states; through one course of the treatment, we will review their symptoms and corresponding indicators of visceral damage。
Primary purpose: TREATMENT

Brief summary: Post-acute sequelae of SARS-CoV-2 infection can cause multiple system function disorders, and complicated symptoms last for an extended period. The virus can cause this continued infection, or the virus causes immune system function disorder and post-infectious autoimmune disease. The clinical symptoms can be smell loss, taste loss to liver function disorder, kidney function failure, different. No matter how complicated the systems showed in the clinic, all of the symptoms are due to the specific cells being damaged. Our clinical study is focused on recovering the damaged structure and function of the cells that could restore the organ function back to normal or close to normal

Detailed description: SARS-CoV-2 caused sequela is a pathological condition, and specific cells are damaged from a prior disease, injury, or attack. Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) is caused by an infection of SARS-CoV-2 and COVID-19 virus. The virus or virus-triggered disorder immunity attacks target tissue(s) and organ(s). No matter name of the virus and the cells, tissue(s), or organ(s), they all belong to the category of antigen and cause an immune response; this can induce inflammation or not depending on the immune system tolerance . While older patients may have an increased risk of developing severe disease or sequelae, young survivors have also reported symptoms months after acute infection of SARS-CoV-2, reported by the British Lung Foundation. Some infected people, referred to as long-haulers, experience a long period of symptoms. Characterization of the etiology and pathophysiology of late sequelae is underway and may reflect organ damage from the acute infection phase; manifestations of a persistent hyperinflammatory state even perform as autoimmune diseases. Rheumatic disease can also occur during the infection of COVID. Ongoing viral activity indicates an inadequate antibody response. Factors in addition to acute illness that may further complicate the picture include physical deconditioning at baseline or after a long disease course, pre-COVID-19 comorbidities, and psychological sequelae following a long or difficult disease course relating to lifestyle changes due to the pandemic. Likely, the persistent sequelae of COVID-19 represent multiple syndromes resulting from distinct pathophysiological processes along the spectrum of disease. So far, no specific medicine has been identified for treating the COVID-19 virus and post-acute sequelae of SARS-CoV-2. Due to the difficulty treating either SARS-CoV-2 or its caused sequelae, there is a very pessimistic suggestion: People must live with COVID-19 forever. Most people who contract coronavirus disease 2019 (COVID-19) infection recover entirely within a few weeks. However, the long-haulers continue to experience symptoms after their initial recovery. This condition has been called post-COVID-19 syndrome or "long COVID-19." Older people and people with many severe medical conditions are the most likely to experience lingering COVID-19 symptoms, but even young, otherwise healthy people can feel unwell for weeks to months after infection. The most common signs and symptoms that linger over time include fatigue, shortness of breath, cough, joint pain, and chest pain. Other long-term signs and symptoms may include muscle pain or headache, fast or pounding heartbeat, loss of smell or taste, memory and concentration or sleep problems, and rash or hair loss, the Mayo Clinic reported.

Virus infections have been long associated with autoimmune diseases, whether multiple sclerosis, diabetes, or myocarditis. Three potential mechanisms for virus-induced autoimmune disease or virus-induced immunopathology are molecular mimicry, bystander activation, and persistent virus infection.

Those prolonged symptoms are consistent with the internal physical pathological process. That can be the virus infection continuing, or the infection triggered an immune reaction in one or more physical locations when a person became infected with the COVID-19 virus.

Here is the critical point: when the structure of cells is destroyed, the result is the affected cell's function will be lost. Does the etiology directly destroy the antigen, or the virus trigger the disorder immunity to destroy the antigen? The results are the same: the antigen is under inflammation. Returning the damaged cells (antigen) to normal or close to normal states is the key to saving lives.

This raises questions concerning how can we protect those cells from becoming damaged and how can we return injured cells to their normal function? Regardless of whether the cell has been damaged directly by the virus infection, or another reason like disordered immunity, my clinical research will show how to solve those medical problems.

Eligibility criteria: Inclusion Criteria:

* The participants must receive medical herbs as a treatment method;
* Participants are not limited by age, sex, race, or location;
* Participants are including infants;
* Participants are including pregnant woman;
* The participants had an infection history of SARS-CoV-2 in past one month;
* The participants provide SARS-CoV-s diagnoses (Molecular or Antigen). Test was \*positive, now hold negative reports
* Participants hold reports of immune system medics, like immunoglobulin M (IgM), immunoglobulin G (IgG);
* Reports that is evidence of specific organ damaged, including assay reports or image reports
* Participants must agree to take medical herbs for at least 3 months as one course continually;
* Participants must agree to repeat the assay and image test to monitor the treatment results;
* Participants must report their Manifestations clearly to investigators;
* Participants must agree to continue the next course of the treatment after the evaluation if it is necessary;
* The treatment goal is to become symptom-free, and experiment assays went to normal

Exclusion Criteria:

* Participants don't want to take medical herbs;
* Participants have symptoms of sequelae but is not caused by SARS-CoV-2 (COVID-19);
* Participants have not symptoms after COVID-19 infection, no assays abnormal either;
* Participants don't want to repeat the experiment assays;
* Participants are in E.R. or ICU during the application or enrollment;

Primary outcomes:
measure: Monitoring symptoms
timeFrame: 3 months as a course
Secondary outcomes:
measure: Monitoring emotion changing
timeFrame: 3 months as a course.
measure: Checking heart burn symptom
timeFrame: 3 months as a course.
measure: Monitoring thyroid function
timeFrame: 3 months as a course
measure: Monitoring liver function
timeFrame: 3 months as a course
measure: Monitoring kidney function
timeFrame: 3 months as a course
Other outcomes:
Locations:
city: Rockville
country: United States
facility: All Natural Medicine Clinic, LLC
state: Maryland
Study officials:
affiliation: All Natural Medicine Clinic, LLC
name: Wanzhu Hou, CMD
role: PRINCIPAL_INVESTIGATOR
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