Fase I Clinical Trial on NK Cells for COVID-19

NCT04634370 | Unknown Phase 1 DMC

• 1 other identifier: 20200210
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. This study aims to investigate the safety and efficacy of intravenous infusion of natural killer cells patients with COVID-19.

Conditions

Covid19; Sars-cov 2

Keywords

Natural Killer Cells; COVID-19; Sars-CoV2

Outcome Measures

Primary Outcomes (6)

• Overall survival

  Assessment of Overall survival at 30 days post intervention

  30 days

• Changes on inflammatory C-reactive protein

  To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein (mg/dL)

  60 days

• Hospital stay

  days of the patients in hospital

  60 days

• Oxygenation index (PaO2/FiO2)

  Evaluation of functional respiratory changes: PaO2 / FiO2 ratio

  60 days

• Improvement in Liao's score (2020)

  Improvement in Liao's score (2020)

  60 days

• Radiological improvement

  Computed tomography Chest assesment will be done to assess improvement in radiological findings of COVID-19

  60 days

Study Arms (1)

Intervention

EXPERIMENTAL

Each patient will receive on dose of intravenous natural killer cell in following levels: Level 1 : 1x106 cells/kg body weight (patients 1 to 3) Level 2: 5x106 cells/kg body weight (patients 4 to 6) Level 3: 1x107 cells/kg body weight (patients 7 to 24)

Biological: Natural Killer Cells infusion

Interventions

Natural Killer Cells infusion BIOLOGICAL

Each patient will receive on dose of intravenous natural killer cell in following levels: Level 1 : 1x106 cells/kg body weight (patients 1 to 3) Level 2: 5x106 cells/kg body weight (patients 4 to 6) Level 3: 1x107 cells/kg body weight (patients 7 to 24)

Intervention

Eligibility Criteria

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

You may qualify if:

• Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain reaction (RT-PCR);
• The patient or legal donor agrees to participate in the study and signs the informed consent;
• Patients with white or yellow criteria according to the score proposed by Liao et al (2020).

You may not qualify if:

• Patient with pregnancy, are planning to become pregnant or breastfeeding;
• Patients with malignant blood-borne diseases such as HIV or syphilis;
• Not consenting for clinical trial;
• Patients with other than white or yellow criteria according to the score proposed by Liao et al (2020).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Lucia Silla, MD, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucia Silla, MD, PhD

CONTACT

55 51 33598371; lsilla@hcpa.edu.br

Annelise Pezzi, PhD

CONTACT

annepezzi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 18, 2020
• Study Start: January 2, 2021
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)