Zofin to Treat COVID-19 Long Haulers

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT05228899

Run by

ZEO ScientifiX, Inc.

People needed

18

Starts

2022-04-14

Expected to finish

2023-10-18

Last updated by the study team

2023-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Beck Depression Inventory (BDI) score <15 at the time of Screening (score of 15 is an exclusion).
• 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.
• Subjects must be reasonably able to return for multiple follow-up visits.
• Adequate venous access.
• For Subjects of Child-Bearing Potential only, willingness to use FDA recommended birth control until 6 months post-treatment. The FDA approved and cleared methods for birth control are listed below:
• Permanent sterilization
• Long-acting reversible contraceptives (LARC)
• Contraceptive injection
• Short-acting hormonal methods
• Barrier methods
• Emergency contraception https://www.fda.gov/consumers/free-publications-women/birthcontrol

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;
• Heart failure of any degree (including NYHA classification Class 1- 4).
• History of migraines prior to COVID-19 infection.
• History of neuropathy prior to COVID-19 infection.
• History of inflammatory and irritable bowel disease prior to COVID-19 infection.
• History of depression and anxiety disorders prior to COVID-19 infection.
• History of chronic fatigue syndrome, fibromyalgia, and arthritic disorders prior to COVID-19 infection.
• Exhibiting signs of moderate or severe chronic respiratory disease (such as COPD, asthma, or pulmonary fibrosis) and history of these illnesses prior to COVID-19 infection.
• Patient with rheumatologic disorders.
• History of chronic liver disease or patient showing signs of clinical jaundice at the time of screening.
• History of severe chronic kidney disease or requiring dialysis.

Where it is running

• NewportNativeMD — Newport Beach, California, United States
• Assuta Family Medical Group — North Hollywood, California, United States
• Innovation Clinical Trials — Miami, Florida, United States
• United Memorial Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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