A clinical study to see effect of ArtemiC in patients with COVID-19

A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19 - ArtemiC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026789

Enrollment

Registered

2020-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: ArtemiC medical spray: ArtemiC is a Oromucosal medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administr

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed SARS-CoV-2 infection. 2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission, and on the other hand not experiencing clinical improvement under ongoing standard care. 3. Age: 18 years old and above. 4. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient). 5. Ability to receive treatment by spray into the oral cavity

Exclusion criteria

Exclusion criteria: 1. Tube feeding or parenteral nutrition. 2. Oxygen requirements beyond use of nozzles or simple mask as per score 4 3. Respiratory decompensation requiring mechanical ventilation. 4. Uncontrolled diabetes type 2. 5. Autoimmune disease. 6. Pregnant or lactating women. 7. Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study. 8. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.

Design outcomes

Primary

Measure	Time frame
1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of â?¤ 2 Maintained for 24 Hours in comparison to routine treatment 2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days	—

Secondary

Measure	Time frame
1.Time until negative PCR 2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms 3.COVID-19 related survival 4.Incidence and duration of mechanical ventilation 5.Incidence of Intensive Care Init (ICU) stay 6.Duration of ICU stay 7.Duration of time on supplemental oxygen 8.Additional Data will be recorded to complete the Core Set of OutcomesTimepoint: 15 Days	—

Measure

Time frame

1.Time until negative PCR 2. Proportion of participants with normalization of fever and oxygen saturation through day 14 since onset of symptoms 3.COVID-19 related survival 4.Incidence and duration of mechanical ventilation 5.Incidence of Intensive Care Init (ICU) stay 6.Duration of ICU stay 7.Duration of time on supplemental oxygen 8.Additional Data will be recorded to complete the Core Set of OutcomesTimepoint: 15 Days

—

Countries

India

Contacts

Public ContactDr Neeta Nargundkar

Biosphere Clinical Research Pvt.Ltd

drneeta@biospherecro.com02241006794

Outcome results

None listed

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