Sars Cov 2 Clinical Trial
Official title:
Treatment in Outpatient Patients With Covid-19 With Methylene Blue and Photodynamic
Within the epidemic context of phase 3 in Mexico, the implementation of new treatments that have been shown to be beneficial for patients in other countries is an urgent need. Methylene blue (MB, the oxidized form, blue color) has been used in many different clinical medicine areas, ranging from malaria to orthopedics. Methylene blue absorbs energy directly from a light source and then transfers this energy to molecules of oxygen creating singlet oxygen (O2), which is the first electronic excited state of molecular oxygen (O2). Singlet oxygen is extremely electrophilic; thus, it can directly oxidize electron-rich double bonds in biological molecules and macromolecules. For this reason, methylene blue has been used as a photosensitizer in the treatment of cancer and the protection of serum from viral agents. Methylene blue can be reactivated using energy from a light source in the body until processed out through the kidneys.
| Status | Recruiting |
| Enrollment | 46 |
| Est. completion date | December 30, 2020 |
| Est. primary completion date | November 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients over 18 years of age - Of both sexes - Confirmed case of Covid-19 (by RT-PCR) and CT less than 32 in the E - That they go to the ER service due to COVID symptoms, and that they voluntarily agree to participate in the study by written the informed consent - With at least 1 of the following symptoms: fever, headache, nausea, dyspnea, myalgia, vomiting, or diarrhea - With chest X-ray without pneumonia criteria - With SO2> 90 - No history of allergic reaction to methylene blue - No history of treatment with medication with methylene blue negative interaction Exclusion Criteria: - Pregnancy and breastfeeding - Preadmission anticoagulation - Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) - Active chronic hepatitis - Patients with history of allergic reaction or significant sensitivity to methylene blue - Treatment with immunosuppressive agents - Diagnosis of cancer at any stage and of any type. - Pregnancy and breastfeeding - Patients who plan to become pregnant during the study period or within 6 months after the end of the study period. - Participation in another clinical trial with an experimental drug in the last 30 days. - Other pathologies that, in the medical opinion, contraindicate participation in the study. - Uncompensated comorbidities |
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Hospital Regional Lic Adolfo Lopez Mateos | Mexico City | Ciudad De Mexico CDMX (Mexico City) |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Reg. Lic. Adolfo Lopez Mateos |
Mexico,
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* Note: There are 28 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change form baseline in Arterial oxygen saturation | Aretrial oxygen saturation will be taken by an oximeter | up to 7 days | |
| Primary | Days to clinical improvement | Number of days of patient discharge | up to 7 days | |
| Secondary | Change Form Baseline in C reactive protein at 7 days | Blood samples will be taken on days 1 and 7 | up to 7 days | |
| Secondary | Change Form Baseline in IL-1ß | Blood samples to analyse IL-1ß will be taken on days 1 and 7. | up to 7 days | |
| Secondary | Change Form Baseline in Erythrocyte sedimentation rate like procalcitonin | Blood samples to analyse the Erythrocyte sedimentation rate like procalcitonin | up to 7 days | |
| Secondary | Change Form Baseline in Ferritin levels | Blood samples to analyse Ferritin levels | up to 7 days | |
| Secondary | Change Form Baseline in D dimer | Blood samples to analyse D dimer will be taken on days 1 and 7 | up to 7 days |