Zofin to Treat COVID-19 Long Haulers

NCT05228899 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 27378
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety and potential efficacy of Zofin administered intravenously in subjects experiencing prolonged symptoms (\> 6 weeks and \< 24 months) of COVID-19.

Conditions

COVID-19

Keywords

COVID-19 Long Hauler; PASC; Zofin; Exosomes; Extracellular Vesicles

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Adverse Events

  To evaluate the safety of Zofin administered intravenously in subjects experiencing prolonged COVID-19 symptoms. To compare the incidence of grade 3 or 4 or serious adverse events (SAEs) in subjects receiving Zofin compared to placebo: * Occurrence of SAEs within 30 days related to the therapy. * Life-threatening event (e.g., stroke or non-fatal pulmonary embolism). * Event requiring inpatient hospitalization (e.g., for worsening dyspnea). * Event resulting in persistent or significant disability/incapacity. * Event resulting in death.

  30 days

Secondary Outcomes (13)

• Fatigue Severity Score Score

  0, 8,14, 30, 60 days

• Daily Diary of COVID-19 Related Symptom

  0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days

• COVID-19 Associated Symptoms Length

  30 days

• COVID-19 Associated Symptoms Mitigation

  30 days

• Beck Depression Inventory Score

  0, 8, 14, 30, 60 days

Study Arms (2)

Group 1: Zofin

EXPERIMENTAL

Group 1 (15 subjects) Fifteen subjects will receive 1 mL of Zofin diluted with 100ml of sterile saline on day 0, day 4 and day 8, containing 2-5 x 10\^11 particles/ml intravenously.

Drug: Zofin

Group 2: Placebo

PLACEBO COMPARATOR

Group 2 (15 subjects) Fifteen subjects will receive 1mL of placebo diluted with 100ml of sterile saline on day 0, day 4 and day 8, containing sterile saline intravenously.

Other: Placebo

Interventions

Zofin DRUG

1mL of Zofin will be administered intravenously, containing 2-5 x 10\^11 particles/mL. Zofin will be diluted in 100 mL of sterile saline.

Also known as: human amniotic fluid

Group 1: Zofin

Placebo OTHER

1mL of Placebo (normal saline) will be diluted in 100 mL of sterile saline and administered intravenously.

Also known as: normal saline

Group 2: Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects age \> 18 years at the time of signing the informed consent form.
• Male or female.
• COVID-19 survivor and had documented SARS-CoV-2 positive (FDA EUA approved RT-PCR or equivalent tests such as FDA EUA approved Rapid Antigen Test which is performed at CLIA certified lab or the readout of the test reviewed and documented by a doctor).
• Subject experiencing fatigue for over 6 weeks after their positive test result while currently being negative.
• Subject has not fully recovered from COVID-19 for at least over 6 weeks despite a negative SARS-COV-02 test.
• Subjects tested positive for anti-SARS-CoV-2 antibodies using FDA EUA approved test.
• Subject is experiencing the following three symptoms for at least over 6 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms i.e., subject didn't have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19:
• Extreme fatigue - feeling overtired with low energy and a strong desire to sleep but unable to have good sleep.
• Body aches - muscle soreness or generalized achiness throughout the body.
• Joint pain - pain in the joints due to inflammation not experienced before illness.
• Chalder Fatigue Scale Bimodal Score ≥ 4 at the time of Screening.
• Fatigue Severity Scale (FSS) ≥ 4 at the time of Screening.
• Fatigue Assessment Scale Score (FAS) ≥ 10.5 at the time of Screening.
• Investigator(s) has access to medical documentation of previous COVID-19 treatments.
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Tested positive for SARS-CoV-2 infection at the time of screening (acute infection) which will involve a nasal swab sample or another FDA-approved test.
• Subjects with a BDI ≥ 15 are excluded.
• Subjects with homicidal or suicidal ideation are excluded.
• Subjects with a diagnosis of depression upon entry into the study must have had at least 2-months of treatment (psychotherapy, antidepressive medication, or both) prior to enrollment, be stable on their current treatment regimen, and be followed by a medical provider who is actively treating and managing their depression throughout the study period.
• Subjects who had recovered fully from COVID-19 and have a new onset of extreme fatigue, body aches, or joint pain that were due to other etiologies, not COVID-19 are excluded.
• Subjects with serious co-morbidities are excluded. For example:
• Liver enzymes are \>2X ULN;
• eGFR is \<60 ml/min by the CKD- EPI equation;
• Hb is \<11 mg/dL;
• Platelet count is \<100K;
• Uncontrolled arrhythmias;
• BP systolic \<90 mmHg or \>160 mmHg;
• Pulse is \<60 or \>100;
• Respiratory rate is \<12 or \>25;
• Abnormal ECG or any signs of active ischemic heart disease;

Sponsors & Collaborators

• ZEO ScientifiX, Inc.: lead

Study Sites (4)

NewportNativeMD

Newport Beach, California, 92663, United States

Location

Assuta Family Medical Group

North Hollywood, California, 91606, United States

Location

Innovation Clinical Trials

Miami, Florida, 33157, United States

Location

United Memorial Medical Center

Houston, Texas, 77091, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

amniotic fluid peptide-1, human; Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Natasha Phrsai

  Proxima

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Neither the patients nor the researchers know who is getting a placebo and who is getting the treatment.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a phase I/II randomized, double blinded and placebo control. The ratio between groups is 1:1 for total 30 subjects. Each subject will be randomized to receive either treatment or placebo.

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 8, 2022
• Study Start: April 14, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 18, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)