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The objective of this study is to evaluate the impact of this HDIVC therapy in the first treatment of symptomatic Covid-19 patients in a time period of one week.
We consider that treatment with high doses of injectable vitamin C HDIVC could have a positive impact as an adjunct on the immunity of patients with Covid while reducing the possibility of worsening their clinical picture. Similarly, we wish to evaluate the efficacy of this treatment, for one week, in patients hospitalized in the ICU, in order to reduce the inflammatory burden and reduce hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 80 patients randomized to group A will receive two doses (High) of vitamin C intravenously, twice a day for seven days. |
|
| Group B | Placebo Comparator | 80 patients assigned to group B will receive two doses of Dextrose 500 mL, twice a day for seven days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High doses of intravenous vitamin C | Drug | Two (2) High doses of intravenous vitamin C for seven (7) days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in worst (highest) | Mean change in worst (highest) oxygenation level (oxygen saturation or oxygen flow in liters/min) in non-ventilated patients. | Seven (7) days after randomization. |
| Mean change in worst (lowest) | Mean change in worst (lowest) PaO2 / FiO2 ratio (in mmHg) in ventilated patients. It should be within the first seven days after randomization. | Seven (7) days after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality | up to day 28 |
| Duration of mechanical ventilation | Duration of mechanical ventilation | Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugo Galindo, MD | Contact | 57 3006292776 | hgalindo@grupogales.com |
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| Dextrose 500 mL | Drug | Application of a vial of LEV in 100 mL of water for injection, which is diluted in 400mL of 5% Dextrose for a final volume of 500mL of intravenous fluids, to be applied to the chosen patient, in a drip of 0.5 grams of the placebo solution per minute, for a total of 60 minutes. Twice a day for seven days. |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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