Observational study of the benefits of rectal ozonotherapy and BIOPLA as complemetary theraphy in convalescent patients with SARS-COV 2

Observational study of the benefits of rectal ozonotherapy and BIOPLA as complementary therapy in convalescent patients with SARS-COV 2 (COVID-19) - EST-OBS-OZO-BIOPLA-SARS-COV 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

RPCEC

Registry ID

RPCEC00000342

Enrollment

Registered

2020-11-06

Start date

2020-06-08

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

COVID-19 COVID-19 SARS-CoV2

Interventions

Group 1: Rectal ozonotherapy in combination with BIOPLA. Rectal ozonotherapy aplication (200 mL gas with 30 µg/mL ozono concentration), 5 days/week during 4 weeks plus BIOPLA (1 capsule-500mg)/dayafte

Medicine, Traditional

Administration, Rectal

Administration, Oral

Ozone therapy, BIOPLA

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Hospitalization patients convalescient with SARS-CoV 2, bewteen 40 and 80 years , both sexes, signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with uncontrolled hypertiroidism 2) Patients with deficit of glucose-6-phosphateo-deshidrogenase 3) Non transmissible cronic diseases 4) Oncological patients 5) Patients with psiquiatric diseases 6) Surgery 7) Patients use inmunosupresant or patients with trasplant 8) Patiens with coagulation , trombocitopenia or active bleed 9) Allergic patients 10) Patients participate in other clinical trials 3 months before

Design outcomes

Primary

Measure	Time frame
Physical-nutritional status (Body mass index [(weight (kg) / height (m)) measured as Poor, Normal, Excessive]; Arm circumference [Assessment of atrophy measured as Presence or Not]; Grip strength [Evolution of sarcopenia measured as Presence or not]).Measurement time: Baseline and, at the end of the 4th week of treatment	—

Secondary

Measure	Time frame
Blood biochemical variables (Albumin (g / L), lactate dehydrogenase (LDH-UI), alanine amino transferase (ALT-U / L), aspartate amino transferase (AST-U / L), creatinine (umol / L), gamma-glutamyl transferase (GGT-U / L), glucose (mmol / L), biliribin (mmol / L), uric acid (mmol / L), cholesterol (mmol / L), triglycerides (mmol / L) and high-density lipoproteins ( HDL-mmol / L)). Measurement time: At baseline and after 4 weeks of treatment. Redox balance indicators (Pro-oxidants MDA and total hydroperoxides, Nitric oxide, Products of advanced protein oxidation; Antioxidants (Glutathione, SOD and CAT)). Measurement time: At baseline and after 4 weeks of treatment. Adverse events-AE (Occurrence of AE in patient (Yes/No); Description of AE (name of AE); Duration of AE (Date of start and stop of the AE); Intensity of AE (mild, moderate, severe); Attitude respect to study treatment (within changes, modification of dose, temporal or definitive interruption of study treatment); Relation of causality (highly probable, probable, possible, improbable, no related, no evaluable)). Measurement time: 4 weeks	—

Measure

Time frame

Blood biochemical variables (Albumin (g / L), lactate dehydrogenase (LDH-UI), alanine amino transferase (ALT-U / L), aspartate amino transferase (AST-U / L), creatinine (umol / L), gamma-glutamyl transferase (GGT-U / L), glucose (mmol / L), biliribin (mmol / L), uric acid (mmol / L), cholesterol (mmol / L), triglycerides (mmol / L) and high-density lipoproteins ( HDL-mmol / L)). Measurement time: At baseline and after 4 weeks of treatment. Redox balance indicators (Pro-oxidants MDA and total hydroperoxides, Nitric oxide, Products of advanced protein oxidation; Antioxidants (Glutathione, SOD and CAT)). Measurement time: At baseline and after 4 weeks of treatment. Adverse events-AE (Occurrence of AE in patient (Yes/No); Description of AE (name of AE); Duration of AE (Date of start and stop of the AE); Intensity of AE (mild, moderate, severe); Attitude respect to study treatment (within changes, modification of dose, temporal or definitive interruption of study treatment); Relation of causality (highly probable, probable, possible, improbable, no related, no evaluable)). Measurement time: 4 weeks

—

Countries

Cuba

Contacts

Public ContactZullyt Zamora Rodriguez

National Center for Scientific Research

zullyt.zamora@cnic.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026