Efficacy of Adaptogens in Patients With Long COVID-19

NCT04795557 | Completed Phase 2 DMC

• 2 other identifiers: SHIRD-2021-01Nr2-2021/86
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial of a fixed combination of standardized extracts from Rhodiola rosea roots, Schisandra chinensis berry and Eleutherococcus senticosus root (ADAPT-232) in COVID-19 patients is to demonstrate possible efficacy of adjuvant treatment with ADAPT-232 in decreasing the duration of the convalescence, alleviation of fatigue, headache, attention deficit, difficult and rapid respiration, depression, anxiety and other symptoms of Long COVID-19 during rehabilitation period.

Conditions

Covid19

Keywords

Long Covid; fatigue; headache; attention disorder,; depression; anxiety

Outcome Measures

Primary Outcomes (4)

• Duration of symptoms of Long COVID:

  Time (days) from randomization to symptoms disappear

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Number of participants clinically recovered

  Number of participants without symptoms of Long COVID

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Length of home stay/ sick listed

  Time (days) at home / sick listed

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Severity of the Long COVID symptoms

  Time from randomization to relief of total and individual Long COVID symptoms scores Patient will be assessed for changes in clinical signs: headache, fatigue, physical activity, depression and anxiety, anosmia, ageusia, hair loss, cough, fever, sweat, pain in muscles, chest, and joints. The medians and hazard ratio's will be measured and compared between groups)

  Change from baseline during the period of the treatment and follow up (trough 21 days after randomization)

Secondary Outcomes (7)

• Hypercoagulation marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Immune response marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Inflammatory marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Physical activity

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Cognitive performance score

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

Other Outcomes (1)

• Time to negative COVID-19 test

  14 days after randomization

Study Arms (2)

ADAPT232

EXPERIMENTAL

50 patients take ADAPT-232® oral solution in the daily dose of 60 ml ( 30 ml two times daily) for 14 days. One mL of oral solution contains: Schisandra chin. fructus native extract 10,0 mg DERnative 2,0-5,0:1 Eleutherococcus sent. radix native extract 2,6 mg DERnative 17-30:1 Rhodiola rosea radix native extract. 3,0 mg DERnative 2,0-5,0:1 Inactive excipients,

Dietary Supplement: ADAPT-232 oral solution

Placebo

PLACEBO COMPARATOR

50 patients take Placebo oral solution in the daily dose of 60 ml ( 30 ml two times daily) for 14 days.

Other: Placebo oral solution

Interventions

ADAPT-232 oral solution DIETARY_SUPPLEMENT

One ml of ADAPT 232/CHISAN oral solution contains: Fructus Schizandrae native extract DERnative 2-4:1, (extraction solvent . 95% ethanol) - 10 mg corresponding to 20-40 mg dried fruit; Radix Eleutherococci native extract DERnative 17-30:1 (extraction solvent - 70% ethanol) - 2.6 mg corresponding to 44-78 mg dried rhizomes, and Radix Rhodiolae native extract DERnative 2-5:1 (extraction solvent - 70% ethanol) - 3 mg corresponding to 6-30 mg dried rhizomes. Excipients

Also known as: Chisan

ADAPT232

Placebo oral solution OTHER

Excipients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19 patients with confirmed diagnosis based on positive SARS-Cov-2 test and the symptom of at least three of Long COVID-19 symptoms including: fatigue, headache, respiration problems (dyspnea or polypnea), sweat, cognitive disorders (attention, memory, anxiety and depression), loss of smell (anosmia) and taste (ageusia), cough, pain in joints. muscles and chest.
• Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission.
• Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
• Able to take medication alone.
• Able to give informed consent.

You may not qualify if:

• Post COVID-19 patients discharged from Covid Hotels isolation, after hospitals and Intensive Care Unit (ICU) admission and Long Covid Symptoms longer that 3 months.
• Patient admitted already under invasive mechanical ventilation;
• Patient admitted with severe acute respiratory syndrome and diagnosed with an etiologic agent other than SARS-CoV-2;
• Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
• Tube feeding or parenteral nutrition.
• Respiratory decompensation requiring mechanical ventilation.
• Uncontrolled diabetes type 2.
• Autoimmune disease.
• Pregnant or lactating women.
• Taking antibiotics for a reason other than COVID-19 at enrollment;
• Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
• Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
• Has active cancer;
• Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
• Already participating in another clinical trial;

Sponsors & Collaborators

• Swedish Herbal Institute AB: lead
• National Family Medicine Training Centre, Georgia: collaborator
• Tbilisi State Medical University: collaborator
• Phytomed AB: collaborator

Study Sites (1)

National Family Medicine Training Centre,

Tbilisi, 0102, Georgia

Location

Related Publications (7)

• Panossian A, Brendler T. The Role of Adaptogens in Prophylaxis and Treatment of Viral Respiratory Infections. Pharmaceuticals (Basel). 2020 Sep 8;13(9):236. doi: 10.3390/ph13090236.

  PMID: 32911682 BACKGROUND

• Brendler T, Al-Harrasi A, Bauer R, Gafner S, Hardy ML, Heinrich M, Hosseinzadeh H, Izzo AA, Michaelis M, Nassiri-Asl M, Panossian A, Wasser SP, Williamson EM. Botanical drugs and supplements affecting the immune response in the time of COVID-19: Implications for research and clinical practice. Phytother Res. 2021 Jun;35(6):3013-3031. doi: 10.1002/ptr.7008. Epub 2020 Dec 29.

  PMID: 33373071 BACKGROUND

• Narimanian M, Badalyan M, Panosyan V, Gabrielyan E, Panossian A, Wikman G, Wagner H. Impact of Chisan (ADAPT-232) on the quality-of-life and its efficacy as an adjuvant in the treatment of acute non-specific pneumonia. Phytomedicine. 2005 Nov;12(10):723-9. doi: 10.1016/j.phymed.2004.11.004.

  PMID: 16323290 BACKGROUND

• Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA, Cuapio A, Villapol S. More than 50 Long-term effects of COVID-19: a systematic review and meta-analysis. medRxiv [Preprint]. 2021 Jan 30:2021.01.27.21250617. doi: 10.1101/2021.01.27.21250617.

  PMID: 33532785 BACKGROUND

• Tenforde MW, Kim SS, Lindsell CJ, Billig Rose E, Shapiro NI, Files DC, Gibbs KW, Erickson HL, Steingrub JS, Smithline HA, Gong MN, Aboodi MS, Exline MC, Henning DJ, Wilson JG, Khan A, Qadir N, Brown SM, Peltan ID, Rice TW, Hager DN, Ginde AA, Stubblefield WB, Patel MM, Self WH, Feldstein LR; IVY Network Investigators; CDC COVID-19 Response Team; IVY Network Investigators. Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network - United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020 Jul 31;69(30):993-998. doi: 10.15585/mmwr.mm6930e1.

  PMID: 32730238 BACKGROUND

• Rogers JP, Chesney E, Oliver D, Pollak TA, McGuire P, Fusar-Poli P, Zandi MS, Lewis G, David AS. Psychiatric and neuropsychiatric presentations associated with severe coronavirus infections: a systematic review and meta-analysis with comparison to the COVID-19 pandemic. Lancet Psychiatry. 2020 Jul;7(7):611-627. doi: 10.1016/S2215-0366(20)30203-0. Epub 2020 May 18.

  PMID: 32437679 BACKGROUND

• Panossian AG, Efferth T, Shikov AN, Pozharitskaya ON, Kuchta K, Mukherjee PK, Banerjee S, Heinrich M, Wu W, Guo DA, Wagner H. Evolution of the adaptogenic concept from traditional use to medical systems: Pharmacology of stress- and aging-related diseases. Med Res Rev. 2021 Jan;41(1):630-703. doi: 10.1002/med.21743. Epub 2020 Oct 25.

  PMID: 33103257 BACKGROUND

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Fatigue; Headache; Cognition Disorders; Depression; Anxiety Disorders

Interventions

ADAPT 232

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neurologic Manifestations; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Irina Karosanidze, PhD, MD

  Director of National Family Medicine Training Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development at Phytomed AB

Model Details: Patients will be randomized in a manner of 1:1 for study drug (ADAPT-232) and Standard of Care to Placebo and Standard of Care. Patient treatment period will last 2 weeks. During this time, patients will be monitored for adverse events. There will be a follow up period in order to check adverse events and study drug efficacy

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 12, 2021
• Study Start: April 19, 2021
• Primary Completion: November 11, 2021
• Study Completion: December 26, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)