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NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia (HOPE)

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: NCT04315987
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Cellavita Pesquisa Científica Ltda
Hospital Vera Cruz
Information provided by (Responsible Party):
Azidus Brasil

Brief Summary:
This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.

Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Biological: NestaCell® Biological: Placebo Phase 2

Detailed Description:

The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.

MSCs have been widely used in cell-based therapy, from basic research to clinical trials Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases.

NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in previous clinical trials.

The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard treatment to treat patients with severe COVID-19 pneumonia. .

Patients included will be randomized to receive 2x10^7 cells (20 million cells) on days 1, 3, 5 and 7.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized (1:1) to receive NestaCell (n=45) or Placebo (n=45).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Clinical Study to Assess the Efficacy of NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: NestaCell®
A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
Biological: NestaCell®
A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
Other Name: Mesenchymal Stem Cell

Placebo Comparator: Placebo
Matching placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.
Biological: Placebo
Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.




Primary Outcome Measures :
  1. Change in Clinical Condition [ Time Frame: 10 days ]
    Ordinal scale (WHO ordinal scale that measures illness severity over time)


Secondary Outcome Measures :
  1. Rate of mortality within 10-days [ Time Frame: 10 days ]
    Evaluation of Pneumonia change

  2. Change of Clinical symptoms - respiratory rate [ Time Frame: 10 days ]
    Evaluation of Pneumonia change

  3. Hypoxia [ Time Frame: 10 days ]
    oxygen saturation

  4. PaO2 / FiO2 ratio [ Time Frame: 10 days ]
    oxygen saturation

  5. CD4+ and CD8+ T cell count [ Time Frame: Days 1, 2, 4, 6 and 8. ]
    Marker of Immunological function

  6. Changes of blood oxygen [ Time Frame: 10 days ]
    PaO2 / FiO2 ratio

  7. Side effects in the treatment group [ Time Frame: 10 days ]
    Number of participants with treatment-related adverse events

  8. Complete blood count, cardiac, hepatic and renal profiles; [ Time Frame: Days 1, 2, 4, 6 and 8. ]
    Complete blood count, ALT, AST, GGT, CK, CKmB and creatinine



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation <95%; ii. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).

Exclusion Criteria:

  1. Patients with autoimmune diseases in the past or screening;
  2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
  3. Known or self-reported HIV or syphilis infected persons;
  4. Have participated in stem cell clinical research;
  5. Pregnant or lactating women or those who have fertility plans in the past year;
  6. The estimated life cycle is less than 48 hours;
  7. Other conditions that the researcher thinks are not suitable for participating in the experiment.
  8. Shock
  9. Continuous use of immunosuppressive agents or organ transplants in the past 6 months;

Information from the National Library of Medicine

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): NCT04315987


Contacts
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Contact: Florentino de Araujo Cardoso Filho +55 19 991232882 florentino.cardoso@hospitalcare.com.br
Contact: Luciana Ferrara +55 19 981428814 luciana.ferrara@azidusbrasil.com.br

Locations
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Brazil
Hospital Vera Cruz
Campinas, São Paulo, Brazil
Contact: Florentino de Araujo Cardoso Filho, MD, PhD    +55 19 991232882    florentino.cardoso@hospitalcare.com.br   
Contact: Luciana Ferrara    +55 19 981428814    luciana.ferrara@azidusbrasil.com.br   
Hospital de Barueri
São Paulo, Brazil
Contact: Paulo Fernando Tierno         
IncCOR
São Paulo, Brazil
Contact: Alexandre Soeiro         
UNIFESP
São Paulo, Brazil
Contact: Ricardo Diaz         
Sponsors and Collaborators
Azidus Brasil
Cellavita Pesquisa Científica Ltda
Hospital Vera Cruz
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04315987    
Other Study ID Numbers: HOPE
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections