Clinical evaluation effects of ZAX.1400.C01 in patients with coronavirus

Clinical evaluation of ZAX.1400.C01 in patients with coronavirus in Valiasr Hospital, Fasa, 2021

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210218050404N2

Enrollment

Registered

2021-09-16

Start date

2021-09-27

Completion date

Unknown

Last updated

2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incidence of inflammation due to the mechanism of COVID19. COVID-19

Interventions

Intervention 1: Intervention group: The medicinal composition of ZAX.1400.C01, in the form of capsules, in two daily doses, is consumed for 14 days. Intervention 2: Control group: The composition of p

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of COVID-19 disease by laboratory test from the patient's lung sputum Age from 18 to 65 years Patient hemoglobin saturation (SPO2) between 85% and 93% Detection of lung involvement percentage by CT scan 20-30 breaths per minute informed consent by participate in the study

Exclusion criteria

Exclusion criteria: liver and kidney diseases diabetes Pregnancy and lactation anticoagulants administration (aspirin, Plavix, warfarin) hypertension History of allergies to plant products Disagreement of the physician in charge of the patient before randomization Inability of the patient to take oral medication

Design outcomes

Primary

Measure	Time frame
Inflammatory mediators of IL6. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: ELISA test.;Mortality. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Duration of hospitalization. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Need oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Equipment used in oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Incidence of Acute respiratory distress syndrome (ARDS). Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Fever. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Cough. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.	—

Measure

Time frame

Inflammatory mediators of IL6. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: ELISA test.;Mortality. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Duration of hospitalization. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Need oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Equipment used in oxygen therapy. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Incidence of Acute respiratory distress syndrome (ARDS). Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Fever. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.;Cough. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.

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Secondary

Measure	Time frame
The patient needs to be hospitalized. Timepoint: Days zero, seven and fourteen after start of the intervention. Method of measurement: clinical check list.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Dakhili Ardestani

Fasa University of Medical Sciences

a.dakhili@fums.ac.ir+98 71 5335 0996

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026