Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Extracellular Vesicle Infusion Therapy for Severe COVID-19 (EXIT COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04493242
Recruitment Status : Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Vikram Sengupta, Direct Biologics, LLC

Brief Summary:
To evaluate the safety and efficacy of intravenous administration of bone marrow derived extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 ARDS Pneumonia, Viral Biological: DB-001 Phase 2

Detailed Description:
EXIT COVID-19 is a multi-center, randomized, double-blinded, placebo-controlled trial that will enroll 60 COVID-19 patients with moderate-to-severe ARDS at three research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, placebo-controlled, randomized clinical trial.
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Extracellular Vesicle Infusion Treatment for Severe COVID-19
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo Biological: DB-001
Bone marrow derived extracellular vesicles.

Experimental: Dose 1 Biological: DB-001
Bone marrow derived extracellular vesicles.

Experimental: Dose 2 Biological: DB-001
Bone marrow derived extracellular vesicles.




Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 28 days ]
    all-cause mortality

  2. median days to recovery [ Time Frame: 28 days ]
    median days to recovery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed and dated informed consent form (either by the individual or by the individual's healthcare proxy).
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18-85.
  4. COVID-19 positive as defined by positive RT-PCR SARS-CoV-2.
  5. Moderate to severe ARDS as defined by modified Berlin definition*, which includes timing within 1 week of known clinical insult or new or worsening respiratory symptoms; bilateral opacities not fully explained by effusions, or lung collapse; respiratory failure not fully explained by cardiac failure or fluid overload; PaO2/FiO2 ≤ 200 mm Hg.
  6. Clinical deterioration as evidenced by down-trending PaO2/FiO2 despite standard of care**.
  7. Acute presentation of hypoxia requiring noninvasive oxygen support such as NC, NRB, BIPAP, HFNC. OR Acute presentation of hypoxic respiratory failure which required intubation and subsequent mechanical ventilation.
  8. If the candidate is either male or females of reproductive potential, he or she must agree to use of double barrier method of highly effective birth control contraception such as condoms with oral contraceptive pill or choose to remain abstinent if already practicing abstinence during the screening period. The duration of required usage of double barrier method OR maintenance of abstinence must include the time from the beginning of the screening period until 90 days following the last dose of the study treatment.

Exclusion Criteria:

  1. Concomitant use of other COVID-19 disease modifying treatments such as Remdesivir, Dexamethasone, Tocilizumab, Ritonavir/Lopinavir, and Hydroxychloroquine. (24 hour washout prior to first dose)
  2. Vulnerable populations such as pregnant patients, children, individuals with severe physical or mental disabilities who cannot provide meaningful consent.
  3. Active malignancy requiring treatment within the last five years.
  4. Major physical trauma in the last 5 days, including motor vehicle accidents, assaults, mechanical falls with sequalae of significant bleeding or craniofacial bruising, and surgeries.
  5. Active tuberculosis or cystic fibrosis.
  6. Severe chronic respiratory disease including chronic obstructive pulmonary disease or pulmonary fibrosis requiring home oxygen > 5L/min.
  7. Use of ECMO during the current hospitalization.
  8. Pre-existing pulmonary hypertension.
  9. Severe pre-existing hepatic impairment (presence of cirrhosis, LFTs ≥ 6x baseline, INR ≥ 2.0).
  10. Pre-existing stage IIIb Chronic Kidney Disease or End Stage Renal Disease prior to onset of COVID-19 (stage I, II, and IIIa are acceptable)
  11. Evidence of irreversible coagulopathy (e.g. frequently occluded vascular access despite anticoagulation,
Layout table for additonal information
Responsible Party: Vikram Sengupta, Principal Investigator, Direct Biologics, LLC
ClinicalTrials.gov Identifier: NCT04493242    
Other Study ID Numbers: DB-001
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vikram Sengupta, Direct Biologics, LLC:
covid19
ARDS
extracellular vesicles
exosome
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Viral
Pneumonia
Blister
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical