Patients who are receiving conventional therapy according to the MOH protocol.

Patients will receive Liquorice cap and Boswellia Serrata gum in addition to conventional therapy

COVID-19

LICORICE CAPSULES; 250 mg standardized extract (25% Glycyrrhizin - 62.5 mg) For 10 days, with measuring blood pressure daily.
Dose:
One capsule, twice daily, before meals. Boswellia serrata Gum Resin; B. serrate contains volatile oils (5-15%), pure resin (55-66%), and mucus (12-23%). The resin contains terpenoids, phenolic compounds, flavonoids, and phenylpropanoids. More than 12 different Boswellic acids have been identified, the amounts of 11-keto-β-boswellic acid KBA is 3-4.7% and acetyl-11-keto-β-boswellic acid(AKBA) is 2.2-2.9%, Dose: 2 gm, 4 times daily For 15 days, Boswellia Gum Resin is administered by chewing for a half-hour

Licorice extract

Faculty of Medicine, Assiut University

Complementary Intervention for COVID-19

Evaluation of The Potential Therapeutic Effects of Licorice and Boswellia Serrata Gum in Egyptian Patients With COVID-19 as a Complementary Medicine

Conversion of RT-PCR indicates positive for novel coronavirus RNA to negative

Decrease number of patients that require respiratory support , management in the Intensive Care Unit (ICU) and need Mechanical Ventilation Support with endotracheal intubation.

A pilot study for evaluation of the potential therapeutic effect of food supplement, licorice extract, and Boswellia Serrata gum

Adel Gomaa

Professor of medical pharmacology

Egyptian Biomedical Research Network

All patients will receive Digoxin without interruption. Doses can be modified individually to reach a serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years and between 0.5-0.8 ng/ml in patients older than 75 years

Kaposi' s Sarcoma

Classic Kaposi' s Sarcoma

Endemic Kaposi' s Sarcoma

Lymph Angio Proliferations

digoxin

Saint-Louis Hospital

Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma

The primary endpoint will be tumor response, at 3 months. Assessed by AIDS Clinical Trials Group (ACTG) criteria ;Complete response (CR) will be defined as the absence of detectable residual disease lasting for at least 4 weeks; patients whose only remaining manifestation of KS are pigmented macules could be classified as having had a complete response if malignant cells are absent on biopsy of at least one lesion. Patients with visceral disease on entry who have complete resolution of cutaneous lesions as described above could be considered to have a CR only if no residual disease was detected on endoscopic or radiographic restaging.

Best overall response during the trial, defined by the best response recorded from the start of treatment until disease progression/recurrence or treatment interruption for any reason

lymphedema (scale of 0 (absence)-3 (painful or oozing), circumference)

Safety and tolerance aspects, they will be assessed in terms of drug toxicity evaluated by clinic and on laboratory parameters and scored according Common Terminology Criteria for Adverse Events v4.0 (CTCAE)

Assistance Publique - Hôpitaux de Paris

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge

5mg/kg IV twice daily for 5 days, then followed by either IV ganciclovir or oral valganciclovir once daily until hospital discharge
IV Ganciclovir: For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

IV Ganciclovir

normal saline IV twice daily for 5 days, then followed by either IV normal saline or oral placebo once daily until hospital discharge
Placebo: For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.

Placebo

Total

Sex: Female, Male

Region of Enrollment

Change between baseline and 14 days post-randomization between placebo & ganciclovir groups

Serum IL-6 Level

Number of participants in baseline negatives with CMV reactivation at any level at day 28

Number of Participants With CMV Reactivation at 28 Days in Plasma

Levels of IL-6 from BALs at 7 days post-randomization

BAL Levels of IL-6

Number of participants experiencing organ system failure at 14 days

Number of Participants With Organ System Failure at 14 Days

Number of ICU days alive and not in the ICU by day 28

Number of Days Alive and Not in the ICU

CMV Disease

Number of patients with greater than one AE of grade 3 or more

Grade 3 AEs or Higher

Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

SF-36 Health Survey

Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma

Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma

CMV reactivation in baseline negatives at any level at day 28 in throat

Incidence of CMV Reactivation at Any Level at 28 Days in Throat

Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat

Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat

CMV AUC in Blood

CMV AUC in Throat

CMV Peak Viral Load in Blood

BAL Levels of IL-8

BAL Levels of TNFa

Plasma Levels of IL-6

Plasma Levels of IL-8

Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.

Plasma Levels of TNF a

Plasma levels of TNF a from day 0 to day 28

Plasma levels of soluble ICAM-1 at day 28

Plasma Levels of Soluble ICAM-1

Peak Plasma levels of soluble ICAM-1 from day 0 to day 28

Peak Plasma Levels of Soluble ICAM-1

Peak Plasma Levels of TNF-a

Peak Plasma Levels of IL-10

Peak Plasma Levels of IL-8

Peak Plasma Levels of IL-6

AUC Plasma levels of IL-6 from day 0 to day 28

AUC Plasma Levels of IL-6

AUC Plasma levels of IL-8 from day 0 to day 28

AUC Plasma Levels of IL-8

AUC Plasma levels of IL-10 from day 0 to day 28

AUC Plasma Levels of IL-10

AUC Plasma levels of TNF-a from day 0 to day 28

AUC Plasma Levels of TNF-a

AUC Plasma levels of soluble ICAM-1 from day 0 to day 28

AUC Plasma Levels of Soluble ICAM-1

Hospital days alive and not hospitalized by day 180

Length of Stay

Hospital days alive and not hospitalized by day 28

Number of participants with organ system failure at 28 days

Organ System Failure at 28 Days

Number of days of mechanical ventilation duration as assessed by ventilator free days

Duration of Mechanical Ventilation as Assessed by Ventilator Free Days

Number of days of mechanical ventilation duration as assessed by ventilator days

Duration of Mechanical Ventilation as Assessed by Ventilator Days

Number of participants with bacteremia and/or fungemia

Bacteremia and/or Fungemia

Mortality

Mortality at 180 Days

Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability

SF-36 Functional Assessment Physical Component

Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability

SF-36 Functional Assessment Mental Component

SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability

SF-36 Functional Assessment Mental Component on Day 1

Number of patients with Serious Adverse Events by day 35

Patients With Serious Adverse Events

Time to neutropenia by 35 days post-randomization

Time to Neutropenia

Number of participants requiring Granulocyte-colony stimulating factor

Use of Granulocyte-colony Stimulating Factor

Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35

Renal Insufficiency

Red blood cell transfusions required per patients by day 35

Red Blood Cell Transfusions Required Per Patients

Platelet Transfusions

Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine.

Clinical Outcomes

Bacteremia and fungemia outcomes among subjects who survive at least 7 days

Bacteremia and Fungemia Outcomes

Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization

Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets

Overall mortality amongst subjects who survive at least 7 days after randomization

Overall Mortality

Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization

Number of Mechanical Ventilated Days

Number of ventilator-free days amongst subjects who survive at least 7 days after randomization

Number of Ventilator-free Days

Number of days in the ICU amongst subjects who survive at least 7 days after randomization

Number of Days in the ICU

Number of ICU-free days amongst subjects who survive at least 7 days after randomization

Number of ICU-free Days

Number of days in the hospital amongst subjects who survive at least 7 days after randomization

Number of Days in the Hospital

Number of hospital-free days amongst subjects who survive at least 7 days after randomization

Number of Hospital-free Days

Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Mortality Among Subjects Mechanically Ventilated From Day 7 to 14

Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Number of Mechanically Ventilated Days Among Subjects by Day 28

Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Number of Ventilator-free Days Among Subjects by Day 28

Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Number of Days in ICU Amongst Subjects by Day 28

Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Number of ICU-free Days Amongst Subjects by Day 28

Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization

Number of Hospital-free Days Among Subjects by Day 28

Overall Study

Dr.Michael Boeckh

Acute Lung Injury

Acute Respiratory Distress Syndrome

Respiratory Failure

For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.

For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
The placebo is an IV solution that does not contain any active medications.

University of Colorado / National Jewish Health / Swedish Medical Center

Northwestern University

Baystate Critical Care Medicine / Tufts University School of Medicine

University of Michigan

Wakeforest University, School of Medicine

The Cleveland Clinic Foundation

Ohio State University Medical Center

The Oregon Clinic

University of Pennsylvania Medical Center

University of Pittsburgh Medical Center

University of Vermont College of Medicine

University of Virginia

Harborview Medical Center

University of Washington Medical Center / Harborview Medical Center

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

A Randomized Double-Blind Placebo-Controlled Trial of Ganciclovir/Valganciclovir for Prevention of Cytomegalovirus Reactivation in Acute Injury of the Lung and Respiratory Failure (The GRAIL Study)

herpes genitalis/hypoxia

Complementary Intervention for COVID-19

Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma

Ganciclovir/Valganciclovir for Prevention of CMV Reactivation in Acute Injury of the Lung and Respiratory Failure

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