Randomized Controlled Trial Of Resveretrol-Copper OR Sodium-Copper-Chlorophyllin Versus Standard Treatment In Severe Covid-19 Cancer Patients.

A Phase-II, Open Label, Randomized Controlled Trial of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment in Cancer patients with SARS-CoV-2 Infection who are Symptomatic Or have Pneumonia for Covid 19.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026514

Enrollment

200

Registered

2020-07-13

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: Resveratrol-Copper tablets: Patients will be administered orally, tablets of R-Cu containing 5.6 mg of Resveratrol and 560 ng of copper, 1 tablet once every 6 hours, from the date of ra

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male and non-pregnant female patients 18 years of age or older. 2.Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen. 3.Pneumonia confirmed by chest imaging 3.Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air 4.Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) 5.Abnormalities in any of these parameters. 6.Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible. 7.Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels.

Exclusion criteria

Exclusion criteria: Asymptomatic or only mildly symptomatic

Design outcomes

Primary

Measure	Time frame
The time to clinical improvement, defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.Timepoint: 10 Days	—

Secondary

Measure	Time frame
1. All-cause mortality at 28 days after randomization (28-day mortality) in all 3 arms. 2. Overall Survival times in days (with any-cause death constituting an event)in all. 3. The proportion of patients with virological positivity, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days. 4. The proportion of patients with clinical improvement at day 14 after randomization. 5.Translational, including biomarker-related, research in banked bio-specimensTimepoint: 1.Day 28 2.Day 28 3.Day 10 4.Day 14 5.Day 5,Day 10,discharge	—

Measure

Time frame

1. All-cause mortality at 28 days after randomization (28-day mortality) in all 3 arms. 2. Overall Survival times in days (with any-cause death constituting an event)in all. 3. The proportion of patients with virological positivity, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days. 4. The proportion of patients with clinical improvement at day 14 after randomization. 5.Translational, including biomarker-related, research in banked bio-specimensTimepoint: 1.Day 28 2.Day 28 3.Day 10 4.Day 14 5.Day 5,Day 10,discharge

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Countries

India

Contacts

Public ContactVIKRAM GOTA

ACTREC, Tata Memorial Centre

vikramgota@gmail.com7715019117

Outcome results

None listed

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