Other substances

Zofin

An amniotic fluid fraction.

Phase of research

Potential treatment - clinical evidence

How it helps

Other treatment

Drug status

Experimental

1
 Supporting references
0
 Contradictory references
2
 AI-suggested references
3
 Clinical trials

General information

Zofin is a formulation of the soluble and extracellular vesicle fraction of human amniotic fluid (Mitrani et al., 2021).

Synonyms

Organicell Flow

 

Supporting references

Link Tested on Impact factor Notes Publication date
Case Report: Administration of Amniotic Fluid-Derived Nanoparticles in Three Severely Ill COVID-19 Patients
Critical severity Case report Mixed substance Extracellular vesicles 		Critically ill COVID-19 patients 5.09

The therapy was safe and clinical improvement was observed in the subjects. Sample size: 3. Dosage: 3 or 4 doses. 

 Mar/17/2021

AI-suggested references

Link Publication date
Proof-of-concept trial of an amniotic fluid-derived extracellular vesicle biologic for treating high risk patients with mild-to-moderate acute COVID-19 infection.
Nov/24/2021
Treatment of a COVID-19 long hauler with an amniotic fluid-derived extracellular vesicle biologic.
Aug/30/2021

Clinical trials

ID Title Status Phase Start date Completion date
NCT04657406 Expanded Access to Zofin for Patients With COVID-19 Available Jan/01/1970 Jan/01/1970
  • Alternative id - 19881-EA
  • Interventions - Drug: Zofin
  • Study type - Expanded Access:Treatment IND/Protocol
  • Study results - No Results Available
  • Locations -
  • Study designs -
  • Enrollment -
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures -
NCT05228899 Zofin to Treat COVID-19 Long Haulers Not yet recruiting Phase 1|Phase 2 Feb/15/2022 Sep/30/2023
  • Alternative id - 27378
  • Interventions - Drug: Zofin|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - NewportNativeMD, Newport Beach, California, United States
  • Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
  • Enrollment - 30
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of Severe Adverse Events|Fatigue Severity Score Score|Daily Diary of COVID-19 Related Symptom|COVID-19 Associated Symptoms Length|COVID-19 Associated Symptoms Mitigation|Beck Depression Inventory Score|Mental Fatigue Questionnaire Score|Pulse Oxygen Saturation|Heart Rate Variability by ECG|Transthoracic echocardiogram|Frequency of Urgent Care|C-reactive protein Levels|D-dimer Levels|Cytokine Levels
NCT04384445 Zofin (Organicell Flow) for Patients With COVID-19 Active, not recruiting Phase 1|Phase 2 Sep/08/2020 Jun/30/2022
  • Alternative id - 19881
  • Interventions - Biological: Zofin|Other: Placebo
  • Study type - Interventional
  • Study results - No Results Available
  • Locations - George C. Shapiro, New York, New York, United States
  • Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
  • Enrollment - 20
  • Age - 18 Years and older   (Adult, Older Adult)
  • Outcome measures - Incidence of any infusion associated adverse events|Incidence of Severe Adverse Events|All Cause Mortality|Survival Rate|Cytokine Levels|D-dimer Levels|C-reactive protein Levels|Quantification of the COVID-19|Improved Organ Failure|Chest Imaging Changes
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