COVID-19Phase 1/2NCT05228899
Zofin to Treat COVID-19 Long Haulers
A Phase 1/2 study testing Zofin in people with COVID-19, run by ZEO ScientifiX, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Zofin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2022to 18 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Any male subject must agree to use contraceptives and not donate sperm during the study.
Who cannot join
- 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:
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- 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.
- Showing signs of severe pneumonia, acute respiratory distress syndrome (ARDS), or respiratory failure needing mechanical ventilation.
- Subjects with a history of bleeding disorders or currently on anticoagulation therapy that cannot be stopped prior to infusion which is not related to previous COVID-19 infection.
- Oxygen-dependent on nasal canula greater than 2-L per minute.
- Patient with pulse oxygen saturation (SpO2) of <94% on room air.
- Active or recently treated malignancies.
- Any unstable condition of clinical significance, e.g., uncontrolled hypertension, unstable angina pectoris, worsening asthma.
- Hydroxychloroquine, oral or parenteral corticosteroids, immunosuppressants, or immunomodulating agents within 7 days prior to the screening visit.
- Albuterol as nebulizer for the off-label treatment of COVID-19 within 7 days prior to the screening visit.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female subjects must undergo a blood pregnancy test at screening which will be within 72 hours of the IP infusion.
- Subject has a body mass index (BMI) greater than 42 kg/m2
- Subject has or had an active infection requiring systemic antibiotics within 12 weeks of enrollment in the study.
- Inability to perform any of the assessments required for endpoint analysis.
- Active listing (or expected future listing) for transplant of any organ.
- Be a solid organ transplant recipient. This does not include prior cell based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
- Have a history of organ or cell transplant rejection.
- History of drug abuse (illegal "street" drugs except marijuana, if it is legal to use in states where patient resides), or prescription medications not being used appropriately for a pre-existing medical condition or alcohol abuse (≥ 5 drinks/day for ˃ 3 months), or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months.
- Patients with untreated HIV infection. However, patients can be enrolled if have been treated for HIV and the test negative for HIV viral load but still test positive for antibodies.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
United Memorial Medical Center
Houston, Texas, 77091
Innovation Clinical Trials
Miami, Florida, 33157
NewportNativeMD
Newport Beach, California, 92663
Assuta Family Medical Group
North Hollywood, California, 91606
About this study
Official title: A Phase I/II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin Infused Intravenous (IV) in Patients Experiencing Prolonged COVID-19 Symptoms (Long-Haulers) vs Placebo.
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.
Read the detailed description
This is a phase I/II randomized, double blinded and placebo control. COVID-19 Long Haulers
In double blinded and placebo control trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. The ratio between groups is 1:1 for total 30 subjects. Each subject will be randomized to receive either treatment or placebo.
A total of 30 subjects will be enrolled and randomized.
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.
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.
- Conditions
- COVID-19
- Being tested
- Zofin, Placebo
- Keywords
- COVID-19 Long Hauler, PASC, Zofin, Exosomes, Extracellular Vesicles
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZofinDrug
Also called human amniotic fluid
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.
PlaceboOther
Also called normal saline
1mL of Placebo (normal saline) will be diluted in 100 mL of sterile saline and administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (13)
Fatigue Severity Score Score
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue.
Measured: 0, 8,14, 30, 60 days
Daily Diary of COVID-19 Related Symptom
Changes in daily COVID-19-Related Symptom Severity Score during the treatment phase
Measured: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days
COVID-19 Associated Symptoms Length
Length of COVID-19 associated symptoms from baseline to Day 30 based on self-assessment using daily and weekly symptom diary.
Measured: 30 days
COVID-19 Associated Symptoms Mitigation
Change from baseline through Day 30 of one or more COVID-19 associated symptoms to an improved status
Measured: 30 days
Beck Depression Inventory Score
The Beck Depression Inventory (BDI) is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Measured: 0, 8, 14, 30, 60 days
Mental Fatigue Questionnaire Score
Mental Fatigue Questionnaire Score is a self-reported scale that measure mental fatigue.
Measured: 0, 8, 14, 30, 60 days
Pulse Oxygen Saturation
A Pulse Oxygen Saturation (SpO2) measures how much oxygen is in someone's blood.
Measured: 0, Days 4, 8, 14, 21,30, 60 days
Heart Rate Variability by ECG
Change from baseline in Heart Rate Variability by ECG at Days 8, 14, and 60.
Measured: 0, 8, 14, 60 days
Transthoracic echocardiogram
Transthoracic echocardiogram measures of left ventricular function, right ventricular function, and Doppler-derived pulmonary artery pressure.
Measured: 0, 8, 60 days
Frequency of Urgent Care
Number and length of patient's doctor/urgent care/emergency room visit.
Measured: 0, 30, 60 days
C-reactive protein Levels
CRP from serum of blood samples.
Measured: 0, 8, 14, 21 days
D-dimer Levels
D-dimer from serum of blood samples methodology using blood samples
Measured: 0, 8, 14, 21 days
Cytokine Levels
Measure IL-6, TNF-alpha etc from serum of blood samples
Measured: 0, 8, 14, 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start14 Apr 2022
- Primary completion1 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZEO ScientifiX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natasha Phrsai, Study director, Proxima Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228899
- Sponsor's protocol ID
- 27378
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multicenter, Randomized, Double Blinded, Placebo Trial to Evaluate the Safety and Potential Efficacy of Zofin Infused Intravenous (IV) in Patients Experiencing Prolonged COVID-19 Symptoms (Long-Haulers) vs Placebo.
- ClinicalTrials.gov ID
- NCT05228899
- Acronym / sponsor ID
- 27378
- Conditions
- COVID-19
- Keywords
- COVID-19 Long Hauler, PASC, Zofin, Exosomes, Extracellular Vesicles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ZEO ScientifiX, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase I/II randomized, double blinded and placebo control. COVID-19 Long Haulers
In double blinded and placebo control trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment. The ratio between groups is 1:1 for total 30 subjects. Each subject will be randomized to receive either treatment or placebo.
A total of 30 subjects will be enrolled and randomized.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Zofin | Experimental | Drug: ZofinGroup 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. |
| Group 2: Placebo | Placebo comparator | Other: PlaceboGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (42 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZofinAlso: human amniotic fluid1mL of Zofin will be administered intravenously, containing 2-5 x 10^11 particles/mL. Zofin will be diluted in 100 mL of sterile saline. | Drug | Group 1: Zofin |
| PlaceboAlso: normal saline1mL of Placebo (normal saline) will be diluted in 100 mL of sterile saline and administered intravenously. | Other | Group 2: Placebo |
Primary outcome
Incidence of Severe Adverse Events
Time frame: 30 days
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.
13 secondary outcomes
Fatigue Severity Score Score
Time frame: 0, 8,14, 30, 60 days
Daily Diary of COVID-19 Related Symptom
Time frame: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 21, 28 days
COVID-19 Associated Symptoms Length
Time frame: 30 days
COVID-19 Associated Symptoms Mitigation
Time frame: 30 days
Beck Depression Inventory Score
Time frame: 0, 8, 14, 30, 60 days
Mental Fatigue Questionnaire Score
Time frame: 0, 8, 14, 30, 60 days
Pulse Oxygen Saturation
Time frame: 0, Days 4, 8, 14, 21,30, 60 days
Heart Rate Variability by ECG
Time frame: 0, 8, 14, 60 days
Transthoracic echocardiogram
Time frame: 0, 8, 60 days
Frequency of Urgent Care
Time frame: 0, 30, 60 days
C-reactive protein Levels
Time frame: 0, 8, 14, 21 days
D-dimer Levels
Time frame: 0, 8, 14, 21 days
Cytokine Levels
Time frame: 0, 8, 14, 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Phrsai study director
Proxima Health, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zofin in people with COVID-19, run by ZEO ScientifiX, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Adverse Events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.