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

NCT04315987 | Completed Phase 2 DMC

• 1 other identifier: HOPE
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Condition

  Ordinal scale (WHO ordinal scale that measures illness severity over time)

  10 days

Secondary Outcomes (8)

• Rate of mortality within 10-days

  10 days

• Change of Clinical symptoms - respiratory rate

  10 days

• Hypoxia

  10 days

• PaO2 / FiO2 ratio

  10 days

• CD4+ and CD8+ T cell count

  Days 1, 2, 4, 6 and 8.

Study Arms (2)

NestaCell®

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

NestaCell® BIOLOGICAL

A dose of 2x10\^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.

Also known as: Mesenchymal Stem Cell

NestaCell®

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

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

You may qualify if:

• \. 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).

You may not qualify if:

• Patients with autoimmune diseases in the past or screening;
• 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;
• Known or self-reported HIV or syphilis infected persons;
• Have participated in stem cell clinical research;
• Pregnant or lactating women or those who have fertility plans in the past year;
• The estimated life cycle is less than 48 hours;
• Other conditions that the researcher thinks are not suitable for participating in the experiment.
• Shock
• Continuous use of immunosuppressive agents or organ transplants in the past 6 months;

Sponsors & Collaborators

• Azidus Brasil: lead
• Cellavita Pesquisa Científica Ltda: collaborator
• Hospital Vera Cruz: collaborator

Study Sites (4)

Hospital Vera Cruz

Campinas, São Paulo, Brazil

Location

Hospital de Barueri

São Paulo, Brazil

Location

IncCOR

São Paulo, Brazil

Location

UNIFESP

São Paulo, Brazil

Location

Study Officials

• Florentino de Araujo Cardoso Filho

  Hospital Vera Cruz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized (1:1) to receive NestaCell (n=45) or Placebo (n=45).

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 20, 2020
• Study Start: June 30, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

BR (4)