Organicell Flow for Patients With COVID-19
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|ClinicalTrials.gov Identifier: NCT04384445|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Corona Virus Infection COVID-19 SARS Acute Respiratory Distress Syndrome||Biological: Organicell Flow Other: Placebo||Phase 1 Phase 2|
A human coronavirus (HCoV-19) has caused the novel coronavirus disease (COVID-19) outbreak worldwide. Common symptoms of COVID-19 include fever, cough, and shortness of breath. The majority of cases result in mild symptoms, but some can progress into pneumonia and multi-organ failure. According to the severity it is divided into mild, normal, severe and critically ill, which is associated with ICU admission and mortality. At present, the standard treatment of COVD-19 patients is oxygen therapy, mechanical ventilation, and medications to maintain blood pressure. As of today, no specific antiviral therapy is available for patients with COVID-19. Immune activation in some patients, and the appearance of cytokine storm syndrome (CSS) is one of the important causes of severe damage to lungs and other organs, which may lead to death. There is an urgent need to develop new interventions to suppress the excessive immune response in a timely manner during the course of disease, protect alveolar function, and reduce lung and systemic organ damage.
Organicell Flow is an acellular, minimally manipulated product, derived from human amniotic fluid (HAF). This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from amniotic stem and epithelial cells. The product contains a mean concentration of 5.24x10^11 particles/mL with a mean mode size of 125.2nm. Surface marker analysis confirmed the presence of exosome associated proteins CD63, CD81, and CD9 in addition to high expression of CD133. The completed sequencing revealed 102 commonly expressed miRNA (with a 100-copy expression minimum). Bioinformatics analysis linked 63 miRNAs to 1216 RNA targets. Major players in the proinflammatory cytokine cascade found to be targeted by miRNA were discovered in Organicell's product include TNF, IL-6, and IL-8. Additionally, a broader array of pro-inflammatory cytokines is also targeted by the collection of miRNA such as FGF2, IFNB1, IGF1, IL36a, IL37, TGF-B2, VEGFA, CCL8, and CXCL12. It has been suggested in published research that inhibition or suppression of this pro-inflammatory cytokine cascade may reduce the severity of symptoms associated with elevated immune response. Furthermore, the miRNA was found to target 148 genes associated with immune response.
The property of Organicell Flow demonstrates the therapeutic potential as a suppressor of cytokine activation for the reduction of COVID-19 infection severity. This study aims to investigate safety and potential efficacy of HAF derived acellular product in subjects suffering form COVID-19 infection with severe acute respiratory syndrome (SARS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The trial has two groups, each with 10 subjects (n=20). All eligible study subjects will be randomized, double blinded, to either the treatment group or placebo group.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double blind: neither subjects nor the investigators who are assessing the patient are award of the treatment assignment until the end of the study.|
|Official Title:||A Phase I/II Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Intravenous Infusion of Organicell Flow for the Treatment of Moderate to SARS Related to COVID-19 Infection vs Placebo|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||October 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Organicell Flow Plus Standard Care
Participants in this group will receive standard of care plus Organicell Flow on day 0, day 4 and day 8.
Biological: Organicell Flow
Biological: Organicell Flow. Organicell Flow will be administered intravenously with 1ml, containing 2-5 x 10^11 particles/mL in addition to the Standard Care. The Organicell Flow dose will be diluted in 100 mL of sterile saline at subject's bedside.
Placebo Comparator: Placebo Plus Standard Care
Participants in this group will receive standard of care plus placebo (Saline) on day 0, day 4 and day 8.
Other: Placebo Placebo (saline) will be administered intravenously with 1ml in addition to the Standard Care. The Placebo dose will be diluted in 100 mL of sterile saline at subject's bedside.
- Incidence of any infusion associated adverse events [ Time Frame: 60 Days ]Safety will be defined by the incidence of any infusion associated adverse events as assessed by treating physician
- Incidence of Severe Adverse Events [ Time Frame: 60 Days ]Safety will be defined by the incidence of severe adverse events as assessed by treating physician
- All Cause Mortality [ Time Frame: 60 Days ]Measured at day 60 or at hospital discharge, whichever comes first.
- Survival Rate [ Time Frame: 60 Days ]Number of participants that are alive at 60 days post first infusion follow up
- Cytokine Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]Measure IL-6, IL-2, TNF-alpha from serum of blood samples
- D-dimer Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]D-dimer from serum of blood samples methodology using blood samples or nose / throat swab
- C-reactive protein Levels [ Time Frame: Day 0, Day 4, Day 8, Day14, Day 21, Day 28 ]CRP from serum of blood samples
- Quantification of the COVID-19 [ Time Frame: Day 0, Day 4, Day 8 ]Viral load by real time RT methodology using blood samples or nose / throat swab
- Improved Organ Failure [ Time Frame: Day 30 ]Improved organ failure within 30 days, including cardiovascular system, coagulation system, liver, kidney and other extra-pulmonary organs using Sequential Organ Failure Assessment (SOFA) score.
- Chest Imaging Changes [ Time Frame: Day o, Day 30 ]
Chest imaging changes for 30 days compare to placebo: 1) Ground-glass opacity,
- 2) Local patchy shadowing, 3) Bilateral patchy shadowing, and 4) Interstitial abnormalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384445
|Contact: Maria Ines Mitrani, MD, PhDemail@example.com|
|United States, Florida|
|Naples, Florida, United States, 34109|
|Contact: George Shapiro, MD|
|United States, Georgia|
|Athens, Georgia, United States, 30606|
|Contact: Marie Saylor, RN, MSN 706-425-1500 firstname.lastname@example.org|
|Principal Investigator:||George C Shapiro, MD, FACC||Chief Medical Officer at Organicell Regenerative Medicine, Inc|
|Principal Investigator:||Maria Ines Mitrani, MD, PhD||Chief Science Officer at Organicell Regenerative Medicine, Inc|
|Principal Investigator:||William Kapp, MD, FAAOS||Co-Investigator|