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Study of plants in the Amazon region with potential against Covid-19

The Brazilian Amazon flora as a natural resource for the development of a platform for choosing new anti-SARS-CoV2 drugs using sensitive point-of-care sensors

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-10b8bzpd
Enrollment
Unknown
Registered
2021-09-09
Start date
2021-05-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Covid-19

Interventions

Eligible patients will be randomly assigned in a ratio of 1:1: 1 to receive the Extract that shows positive results in the in vitro assays: Group 1: Sachet-shaped extract The first treatment will be
B04.820.578.500.540.150.113.968

Sponsors

Universidade Federal do Tocantins
Lead Sponsor
Universidade Federal do Tocantins
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age with a diagnosis of SARS-CoV-2 infection, confirmed by PCR-RT Swab test

Exclusion criteria

Exclusion criteria: Exclusion criteria include pregnancy or lactation, known hypersensitivity to the extract to be administered, active cancer, human immunodeficiency virus carriers, patients undergoing solid organ or bone marrow transplantation or using immunosuppressive drugs, bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization, inability to use medication by mouth or nasoenteral tube, known liver failure, or advanced heart failure (New York Heart Association [NYHA] class III or IV).

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the analysis of clinical symptoms (fever, cough, body pain, malaise), obtained through the information provided by the patient, daily, during the 5 days of treatment, classified as strong, moderate and mild during this time, the results being compared with the control group (Placebo).

Secondary

MeasureTime frame
It is expected a decrease in the rates of change in laboratory tests (Hemogram, TGP, TGO, Creatinine, C-Reactive Protein), which are performed before the start of treatment and on the 7th day after the start of treatment, for comparison between the two results.;A decrease in viral load is expected, to be verified through the CT index performed using the RT-PCR technique. This exam will be performed before starting treatment, and also on the 7th day after starting treatment. Comparisons of patients' CT values will be performed.

Countries

Brazil

Contacts

Public ContactRaimundo Aguiar
rwsa@uft.edu.br+55-063-33113516

Outcome results

None listed

Source: REBEC (via WHO ICTRP)