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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
18
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
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.
Time frame: 30 days
Fatigue Severity Score Score
The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue.
Time frame: 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
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
Length of COVID-19 associated symptoms from baseline to Day 30 based on self-assessment using daily and weekly symptom diary.
Time frame: 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
Time frame: 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.
Time frame: 0, 8, 14, 30, 60 days
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Mental Fatigue Questionnaire Score
Mental Fatigue Questionnaire Score is a self-reported scale that measure mental fatigue.
Time frame: 0, 8, 14, 30, 60 days
Pulse Oxygen Saturation
A Pulse Oxygen Saturation (SpO2) measures how much oxygen is in someone's blood.
Time frame: 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.
Time frame: 0, 8, 14, 60 days
Transthoracic echocardiogram
Transthoracic echocardiogram measures of left ventricular function, right ventricular function, and Doppler-derived pulmonary artery pressure.
Time frame: 0, 8, 60 days
Frequency of Urgent Care
Number and length of patient's doctor/urgent care/emergency room visit.
Time frame: 0, 30, 60 days
C-reactive protein Levels
CRP from serum of blood samples.
Time frame: 0, 8, 14, 21 days
D-dimer Levels
D-dimer from serum of blood samples methodology using blood samples
Time frame: 0, 8, 14, 21 days
Cytokine Levels
Measure IL-6, TNF-alpha etc from serum of blood samples
Time frame: 0, 8, 14, 21 days